DRAFTS IN WIDE CIRCULATION DOCUMENT DESPATCH ADVICE MHD 10/ T- 36, 37,38,39,40,41,43,44,45,48, 30/10/2015 TECHNICAL COMMITTEE: MHD 10

Transcription

1 भ रत य म नक य र म मल उपभ ),एव स व ज नक वतरण म र लय,भ रत सरक र ( BUREAU OF INDIAN STANDARDS (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन,9 बह द रश ह जफर म ग, नई द ल Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi द रभ ष Phones : / / व बस ईट Website : DRAFTS IN WIDE CIRCULATION DOCUMENT DESPATCH ADVICE Ref Date MHD 10/ T- 36, 37,38,39,40,41,43,44,45,48, 30/10/ ,52, 55 TECHNICAL COMMITTEE: MHD 10 ADDRESSED TO: 1. All members of Medical Laboratory Instruments Sectional Committee, MHD All Members of Medical Equipment and Hospital Planning Division Council (MHDC) 3. All others interested Dear Madam/Sir(s), Please find enclosed the following documents: Doc No.: MHD 10(0470)/ ISO :2005 TITLE : Containers and accessories for pharmaceutical preparations -- Part 1: Drop-dispensing glass bottles Doc No.: MHD 10(0471)/ ISO :2005 TITLE : Containers and accessories for pharmaceutical preparations -- Part 2: Screw-neck glass bottles for syrups Doc No.: MHD 10(0472)/ISO :2005 Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms Doc No.: MHD 10(0473)/ISO :2005 TITLE : Containers and accessories for pharmaceutical preparations -- Part 4: Tablet glass bottles Doc No.: MHD 10(0474)/ISO :1997 TITLE : Containers and accessories for pharmaceutical preparations -- Part 5: Dropper assemblies Doc No.: MHD 10(0475)/ISO :1998 TITLE : Containers and accessories for pharmaceutical preparations -- Part 7: Screw-neck vials made of glass tubing for liquid dosage forms Doc No.: MHD 10(0476)/ISO :2004 TITLE : Pen systems -- Part 1: Glass cylinders for pen-injectors for medical use Doc No.: MHD 10(0477)/ISO :2011 TITLE : Pen systems -- Part 2: Plunger stoppers for pen-injectors for medical use Doc No.: MHD 10(0478)/ ISO 15137:2005 TITLE : Self-adhesive hanging devices for infusion bottles and injection vials -- Requirements and test methods Doc No.: MHD 10(0479)/ISO 15010:1998 TITLE : Disposable hanging devices for transfusion and infusion bottles - Requirements and test methods

2 Doc No.: MHD 10(0480)/ISO :2012 TITLE : Pen systems -- Part 3: Seals for pen-injectors for medical use Doc No.: MHD 10(0481)/ISO 28620:2010 TITLE : Medical devices -- Non-electrically driven portable infusion Devices Doc No.: MHD 10(0482)/ISO 15378:2011 TITLE : Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) Kindly examine the draft standard and forward your views stating any difficulties, which you are likely to experience in your business or profession, if these are finally adopted as National Standard. Last date for comments: 27/01/2016 Comments if any, may please be made in the format indicated and mailed to the undersigned at the above address. In case no comments are received or comments received are of editorial nature, you will kindly permit us to presume your approval for the above document as finalized. However, in case comments of technical nature are received then it may be finalized either in consultation with the Chairman, Sectional Committee or referred to the Sectional committee for further necessary action if so desired by the Chairman, Sectional Committee. Thanking you, Yours sincerely, Encl: As above (D K Agrawal) Scientist F & Head (MHD) Bureau of Indian Standards 9, B. S. Zafar Marg New Delhi ) priyankamehra@bis.org.in 2) mhd@bis.org.in Telefax:

3 भ रत य म नक य र (उपभ म मल,एव स व ज नक वतरण म र लय,भ रत सरक र) BUREAU OF INDIAN STANDARDS (Ministry of Consumer Affairs, Food & Public distribution, Govt. of India) म नक भवन,9 बह द रश ह जफर म ग, नई द ल Manak Bhavan, 9 Bahadur shah Zafar Marg, New Delhi द रभ ष Phones : / / व बस ईट Website : य पक प रचलन म मस द स दभ एम एच ड 10/ ट 36, 37,38,39,40,41,43,44,45,48, 51,52, 55 दन क 30/10/2015 तकन क स म त एम एच ड 10 प न व ल क न म म डकल रय गश ल उपकरण वषयस म त, एम.एच.ड 10 क सभ सद य च क स उपकरण एवम अ पत ल आय जन वभ ग प रषद अ य सभ च रखन व ल रय मह दय/मह दय, न न ल खत रल ख सल न ह 1. रल ख स य एम एच ड 10 (0470) आईएसओ :2005 श ष क : दव क त य र क लए क ट नर और स म न - भ ग 1: क च क ब तल ब द - वतरण 2. रल ख स य एम एच ड 10 (0471) आईएसओ :2005 श ष क : दव क त य र क लए क ट नर और स म न - भ ग 2: सरप क लए प च गद न क च क ब तल 3. रल ख स य एम एच ड 10 (0472) आईएसओ :2005 श ष क : दव क त य र क लए क ट नर और स म न - भ ग 3: ठ स और तरल ख र क प क लए (व रल) प च गद न क च क ब तल

4 4. रल ख स य एम एच ड 10 (0473) आईएसओ :2005 श ष क : दव क त य र क लए क ट नर और स म न - भ ग 4: ग ल क च क ब तल 5. रल ख स य एम एच ड 10 (0474) आईएसओ :1997 श ष क : दव क त य र क लए क ट नर और स म न - भ ग 5: र पर वध नसभ ओ 6. रल ख स य एम एच ड 10 (0475) आईएसओ :1998 श ष क : दव क त य र क लए क ट नर और स म न - भ ग 7: तरल ख र क प क लए ल स य ब ग क बन प च गद न श शय 7. रल ख स य एम एच ड 10 (0476) आईएसओ :2004 श ष क : प न स टम - भ ग 1: च क स उपय ग क लए कलम - इ ज टर क लए ल स सल डर 8. रल ख स य एम एच ड 10 (0477) आईएसओ :2011 श ष क : च क स उपय ग क लए कलम - इ ज टर क लए सव र ड ट : भ ग 2 - प न रण लय 9. रल ख स य एम एच ड 10 (0478) आईएसओ 15137:2005 श ष क : आव यकत ओ और पर ण तर क - आसव क ब तल और इ ज शन श शय क लए वय चपकन व ल फ स उपकरण 10. रल ख स य एम एच ड 10 (0479) आईएसओ 15010:1998 श ष क : आध न और नष चन क ब तल क लए ड प ज बल फ स उपकरण - आव यकत ओ और पर ण तर क 11. रल ख स य एम एच ड 10 (0480) आईएसओ :2012 श ष क : च क स उपय ग क लए कलम - इ ज टर क लए जव न : भ ग 3 - प न रण लय

5 12. रल ख स य एम एच ड 10 (0481) आईएसओ 28620:2010 श ष क : म डकल उपकरण - ग र व य त च लत प ट बल अक डव इस ज 13. रल ख स य एम एच ड 10 (0482) आईएसओ 15378:2011 श ष क : औषध य उ प द क लए र थ मक प क ज ग स मर - आईएसओ 9001 क आव दन क लए वश ष आव यकत ओ : 2008, अ छ व नम ण अ य स क स दभ म (ज एमप ) क य इन म नक मस द क अवल कन कर और अपन स म तय यह बत त ह ए भ ज क अ तत य द य म नक र र य म नक क प म रक शत ह ज य त इन पर अमल करन म आपक यवस ए अथव क र ब र म य क ठन इय आ सकत ह स म तय य द क ई ह त क य अगल प ट पर दय गय पर म अध ह त र क उप र ल खत पत पर भ ज द स म तय भ जन क अ तम त थ : 27/01/2016 य द क ई स म त र त नह ह त ह अथव स म त म क वल भ ष स ब ध र ट ह ई त उपर त रल ख क यथ वत अ तम प द दय ज य ग य द क ई स म त तकन क रक त क ह ई त वषय स म त क अ य क पर मश स अथव उनक इ छ पर आग क क य व ह क लय वषय स म त क भ ज ज न क ब द रल ख क अ तम प द दय ज य ग ध यव द भवद य स ल नक : उपर त (ड क अरव ल) व नक एफ एव रमख (एम एच ड ) ईम ल1) priyankamehra@bis.org.in 2) mhd@bis.org.in फ न :

6 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (0470)/ISO :2005 TITLE : Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottles LAST DATE OF COMMENTS: 27/01/2016 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

7 Draft for Comments only Doc No: MHD 10 (0470) ISO :2005 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottles Last date of receipt of comments is 27/01/2016 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :2005 'Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing glass bottles' issued by the International Organization for Standardization. The other parts of this standard are: Part 2: Screw-neck glass bottles for syrups Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms Part 4: Tablet glass bottles Part 5: Dropper assemblies Part 7: Screw-neck vials made of glass tubing for liquid dosage forms The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards ISO 719:1985 Glass Hydrolytic IS 2303 (Part 1/Sec 1) : 2012 resistance of glass grains at 98 C Grading Glass: Part 1 Method Method of test and classification of Test and Classification: Section 1 Hydrolytic Resistance of Glass Grains at 98 C (Second Revision) Degree of Equivalence Identical

8 ISO 720:1985 Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification ISO 1101:2004 Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out IS 2303 (Part 1/Sec 2) : 2012 Grading Glass: Part 1 Method of Test and Classification Section 2 Hydrolytic Resistance of Glass Grains at 121 C (Second Revision) IS 8000 (Part 1) : 1985 Geometrical tolerancing on Technical Drawings Part 1 Tolerances of form orientation, location and Run-out and appropriate geometrical definitions (First Revision) Identical Identical The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications Title ISO :1988 Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification ISO :1988 Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification ISO 7459:2004 ISO 8113:2004 Glass containers Thermal shock resistance and thermal shock endurance Test methods Glass containers Resistance to vertical load Test method For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

9 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

10 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (0471)/ISO :2005 TITLE : Containers and accessories for pharmaceutical preparations Part 2: Screw-neck glass bottles for syrups LAST DATE OF COMMENTS: 27/01/2016 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

11 Draft for Comments only Doc No: MHD 10 (0471) ISO :2005 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Containers and accessories for pharmaceutical preparations Part 2: Screw-neck glass bottles for syrups Last date of receipt of comments is 27/01/2016 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :2005 'Containers and accessories for pharmaceutical preparations Part 2: Screw-neck glass bottles for syrups' issued by the International Organization for Standardization. The other parts of this standard are: Part 1: Drop-dispensing glass bottles Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms Part 4: Tablet glass bottles Part 5: Dropper assemblies Part 7: Screw-neck vials made of glass tubing for liquid dosage forms The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards ISO 719:1985 Glass Hydrolytic IS 2303 (Part 1/Sec 1) : 2012 resistance of glass grains at 98 C Grading Glass: Part 1 Method Method of test and classification of Test and Classification: Section 1 Hydrolytic Resistance of Glass Grains at 98 C (Second Revision) Degree of Equivalence Identical

12 ISO 720:1985 Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification ISO 1101:2004 Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out IS 2303 (Part 1/Sec 2) : 2012 Grading Glass: Part 1 Method of Test and Classification Section 2 Hydrolytic Resistance of Glass Grains at 121 C (Second Revision) IS 8000 (Part 1) : 1985 Geometrical tolerancing on Technical Drawings Part 1 Tolerances of form orientation, location and Run-out and appropriate geometrical definitions (First Revision) Identical Identical The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications Title ISO :1988 Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification ISO :1988 Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification ISO 7459:2004 Glass containers Thermal shock resistance and thermal shock endurance Test methods ISO 8113:2004 Glass containers Resistance to vertical load Test method For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

13 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

14 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (0472)/ISO :2005 TITLE: Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms LAST DATE OF COMMENTS: 27/01/2016 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

15 Draft for Comments only Doc No: MHD 10 (0472) ISO :2005 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms Last date of receipt of comments is 27/01/2016 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :2005 'Containers and accessories for pharmaceutical preparations -- Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms' issued by the International Organization for Standardization. The other parts of this standard are: Part 1: Drop-dispensing glass bottles Part 2: Screw-neck glass bottles for syrups Part 4: Tablet glass bottles Part 5: Dropper assemblies Part 7: Screw-neck vials made of glass tubing for liquid dosage forms The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards ISO 719:1985 Glass Hydrolytic IS 2303 (Part 1/Sec 1) : 2012 resistance of glass grains at 98 C Grading Glass: Part 1 Method Method of test and classification of Test and Classification: Section 1 Hydrolytic Resistance of Glass Grains at 98 C (Second Revision) Degree of Equivalence Identical

16 ISO 720:1985 Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification ISO 1101:2004 Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out IS 2303 (Part 1/Sec 2) : 2012 Grading Glass: Part 1 Method of Test and Classification Section 2 Hydrolytic Resistance of Glass Grains at 121 C (Second Revision) IS 8000 (Part 1) : 1985 Geometrical tolerancing on Technical Drawings Part 1 Tolerances of form orientation, location and Run-out and appropriate geometrical definitions (First Revision) Identical Identical The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications Title ISO :1988 Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification ISO :1988 Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification ISO 7459:2004 Glass containers Thermal shock resistance and thermal shock endurance Test methods ISO 8113:2004 Glass containers Resistance to vertical load Test method For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

17 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

18 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (0473)/ISO :2005 TITLE: Containers and accessories for pharmaceutical preparations -- Part 4: Tablet glass bottles LAST DATE OF COMMENTS: 27/01/2016 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

19 Draft for Comments only Doc No: MHD 10 (0473) ISO :2005 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Containers and accessories for pharmaceutical preparations -- Part 4: Tablet glass bottles Last date of receipt of comments is 27/01/2016 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :2005 'Containers and accessories for pharmaceutical preparations -- Part 4: Tablet glass bottles' issued by the International Organization for Standardization. The other parts of this standard are : Part 1: Drop-dispensing glass bottles Part 2: Screw-neck glass bottles for syrups Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms Part 5: Dropper assemblies Part 7: Screw-neck vials made of glass tubing for liquid dosage forms The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards ISO 719:1985 Glass Hydrolytic IS 2303 (Part 1/Sec 1) : 2012 resistance of glass grains at 98 C Grading Glass: Part 1 Method Method of test and classification of Test and Classification: Section 1 Hydrolytic Resistance of Glass Grains at 98 C (Second Revision) Degree of Equivalence Identical

20 ISO 720:1985 Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification ISO 1101:2004 Geometrical Product Specifications (GPS) Geometrical tolerancing Tolerances of form, orientation, location and run-out IS 2303 (Part 1/Sec 2) : 2012 Grading Glass: Part 1 Method of Test and Classification Section 2 Hydrolytic Resistance of Glass Grains at 121 C (Second Revision) IS 8000 (Part 1) : 1985 Geometrical tolerancing on Technical Drawings Part 1 Tolerances of form orientation, location and Run-out and appropriate geometrical definitions (First Revision) Identical Identical The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications Title ISO :1988 Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification ISO :1988 Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification ISO 7459:2004 Glass containers Thermal shock resistance and thermal shock endurance Test methods ISO 8113:2004 Glass containers Resistance to vertical load Test method For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

21 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

22 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (0474)/ISO :1997 TITLE: Containers and accessories for pharmaceutical preparations -- Part 5: Dropper assemblies LAST DATE OF COMMENTS: 27/01/2016 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

23 Draft for Comments only Doc No: MHD 10 (0474) ISO :1997 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Containers and accessories for pharmaceutical preparations -- Part 5: Dropper assemblies Last date of receipt of comments is 27/01/2016 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :1997 Containers and accessories for pharmaceutical preparations -- Part 5: Dropper assemblies' issued by the International Organization for Standardization. The other parts of this standard are: Part 1: Drop-dispensing bottles Part 2: Screw-neck bottles for syrups Part 3: Screw-neck bottles (veral) for solid and liquid dosage forms Part 4: Tablet bottles Part 7: Screw-neck vials made of glass tubing for liquid dosage forms The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards ISO 719:1985 Glass Hydrolytic IS 2303 (Part 1/Sec 1) : 2012 resistance of glass grains at 98 C Grading Glass: Part 1 Method Method of test and classification of Test and Classification: Section 1 Hydrolytic Resistance of Glass Grains at 98 C (Second Revision) Degree of Equivalence Identical

24 ISO 720:1985 Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification IS 2303 (Part 1/Sec 2) : 2012 Grading Glass: Part 1 Method of Test and Classification Section 2 Hydrolytic Resistance of Glass Grains at 121 C (Second Revision) Identical The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications Title ISO :1988 Injection containers for injectables and accessories Part 2: Closures for injection vials ISO :1996 Containers and accessories for pharmaceutical preparations Part 1: Drop-dispensing bottles For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

25 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

26 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (0475)/ISO :1998 TITLE: Containers and accessories for pharmaceutical preparations -- Part 7: Screw-neck vials made of glass tubing for liquid dosage forms LAST DATE OF COMMENTS: 27/01/2016 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

27 Draft for Comments only Doc No: MHD 10 (0475) ISO :1998 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Containers and accessories for pharmaceutical preparations -- Part 7: Screw-neck vials made of glass tubing for liquid dosage forms Last date of receipt of comments is 27/01/2016 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO :1998 Containers and accessories for pharmaceutical preparations -- Part 7: Screw-neck vials made of glass tubing for liquid dosage forms' issued by the International Organization for Standardization. The purpose of this draft Indian Standard is to specify the dimensions, capacities, form and requirements of screw-neck vials made from tubular glass intended for medical use. Vials made from glass tubing are considered to be suitable for the packaging and storage of pharmaceutical preparations until they are administered for medicinal purposes. Such vials may be made of different types of glass which can affect chemical resistance properties. For example, those made from borosilicate glass will have a very high level of chemical resistance where others made from soda-lime-silica glass will have a lower but adequate chemical resistance for the purposes for which they are intended. Because vials may be made from different types of glass and because it is the chemical behavior of the internal surface which is important when they are filled with pharmaceutical preparations, it is essential to specify the test procedures by which this performance can be measured. The other parts of this standard are: Part 1: Drop-dispensing bottles Part 2: Screw-neck bottles for syrups Part 3: Screw-neck bottles (veral) for solid and liquid dosage forms Part 4: Tablet bottles Part 5: Dropper assemblies The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard.

28 b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards ISO 719:1985 Glass Hydrolytic IS 2303 (Part 1/Sec 1) : 2012 resistance of glass grains at 98 C Grading Glass: Part 1 Method Method of test and classification of Test and Classification: Section 1 Hydrolytic Resistance of Glass Grains at 98 C ISO 720:1985 Glass Hydrolytic resistance of glass grains at 121 C Method of test and classification (Second Revision) IS 2303 (Part 1/Sec 2) : 2012 Grading Glass: Part 1 Method of Test and Classification Section 2 Hydrolytic Resistance of Glass Grains at 121 C (Second Revision) Degree of Equivalence Identical Identical The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications Title ISO :1988 ISO :1988 Glass Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification Glass Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

29 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

30 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (0476)/ISO :2004 TITLE: Pen systems -- Part 1: Glass cylinders for pen-injectors for medical use LAST DATE OF COMMENTS: 27/01/2016 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

31 Draft for Comments only Doc No: MHD 10 (0476) ISO :2004 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Pen systems -- Part 1: Glass cylinders for pen-injectors for medical use Last date of receipt of comments is 27/01/2016 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO : 2004 Pen systems -- Part 1: Glass cylinders for pen-injectors for medical use ' issued by the International Organization for Standardization. The other parts of this standard are: Part 2: Plungers and discs for pen-injectors for medical use Part 3: Seals for pen-injectors for medical use The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards ISO 720:1985 Glass Hydrolytic IS 2303 (Part 1/Sec 2) : 2012 resistance of glass grains at 121 C Grading Glass: Part 1 Method Method of test and classification of Test and Classification Section 2 Hydrolytic Resistance of Glass Grains at 121 C (Second Revision) Degree of Equivalence Identical

32 The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications Title ISO ISO Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 1: Determination by titration method and classification Glassware Hydrolytic resistance of the interior surfaces of glass containers Part 2: Determination by flame spectrometry and classification For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

33 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

34 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (0477)/ISO :2011 TITLE: Pen systems -- Part 2: Plunger stoppers for pen-injectors for medical use LAST DATE OF COMMENTS: 27/01/2016 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

35 Draft for Comments only Doc No: MHD 10 (0477) ISO :2011 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Pen systems -- Part 2: Plunger stoppers for pen-injectors for medical use Last date of receipt of comments is 27/01/2016 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO : 2011 'Pen systems -- Part 2: Plunger stoppers for pen-injectors for medical use' issued by the International Organization for Standardization. The other parts of this standard are: Part 1: Glass cylinders for pen-injectors for medical use Part 3: Seals for pen-injectors for medical use The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards ISO 48 Rubber, vulcanized or IS 3400 (Part 2): 2014 Methods thermoplastic Determination of of Test for Vulcanized Rubber hardness (hardness between 10 IRHD Part 2 Rubber, Vulcanized or and Thermoplastic - Determination 100 IRHD) of Hardness (Hardness Between 10 IRHD and 100 IRHD) (Fourth Revision) Degree of Equivalence Identical

36 ISO Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness) IS 3400 (Part 23) : 2002 Methods of Test for Vulcanized Rubbers - Part 23 : Rubber - Determination of Indentation Hardness by Means of Pocket Hardness Meters Identical with ISO 7619:1997 The technical committee responsible for the preparation of this standard has reviewed the provisions of the following International Standards referred in this adopted standard and has decided that they are acceptable for use in conjunction with this standard: International Standard/ Other publications Title ISO 3302 (all parts) Rubber Tolerances for products ISO Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates ISO Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods ISO ISO Pen systems Part 1: Glass cylinders for pen-injectors for medical use Pen systems Part 3: Seals for pen-injectors for medical use For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

37 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

38 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (0478)/ISO 15137:2005 TITLE: Self-adhesive hanging devices for infusion bottles and injection vials -- Requirements and test methods LAST DATE OF COMMENTS: 27/01/2016 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

39 Draft for Comments only Doc No: MHD 10 (0478) ISO 15137:2005 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Self-adhesive hanging devices for infusion bottles and injection vials -- Requirements and test methods Last date of receipt of comments is 27/01/2016 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO 15137:2005 'Self-adhesive hanging devices for infusion bottles and injection vials -- Requirements and test methods' issued by the International Organization for Standardization. Self-adhesive hanging devices have become a common method for hanging infusion containers. The application is easy because no further equipment is needed. The intended purpose of selfadhesive hanging devices is to provide a simple and safe hanging of infusion containers during the administration of liquid pharmaceutical products. The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards ISO :1989 General tolerances IS 2102 (Part1) : 1993 General Part 1: Tolerances for linear and tolerances Part 1 Tolerances for angular dimensions without linear and angular dimensions individual tolerance indications without individual tolerance indications (Third Revision) Degree of Equivalence Identical

40 For the purpose of deciding whether a particular requirement of this standard is complied with, the final value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in accordance with IS 2:1960 Rules for rounding off numerical values (revised). The number of significant places retained in the rounded off value should be same as that of the specified value in this standard.

41 The technical content of the document is not available on website. For details, please contact: Head Medical Equipment and Hospital Planning Department Bureau of Indian Standards 9 Bahadur Shah Zafar Marg New Delhi mhd@bis.org.in hmhd@bis.org.in

42 FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS (Please use A4 size sheet of paper only and type within fields indicated. Comments on each clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should include reasons for the comments and suggestions for modified wording of the clauses when the existing text is found not acceptable. Adherence to this format facilitates Secretariat s work) DOC NO: MHD 10 (0479)/ISO 15010:1998 TITLE: Disposable hanging devices for transfusion and infusion bottles - Requirements and test methods LAST DATE OF COMMENTS: 27/01/2016 NAME OF THE COMMENTATOR/ORGANIZATION: Sl. No. Clause/Subclause/ para/table/fig. No. commented Commentator/ Organization/ Abbreviation Type of Comments (General/Editorial/ Technical) Justification Proposed change

43 Draft for Comments only Doc No: MHD 10 (0479) ISO 15010:1998 BUREAU OF INDIAN STANDARDS (Not to be reproduced without permission of BIS or used as standard) Draft Indian Standard Disposable hanging devices for transfusion and infusion bottles - Requirements and test methods Last date of receipt of comments is 27/01/2016 Medical Laboratory Instruments Sectional Committee, MHD 10 NATIONAL FOREWORD (Formal clause of adoption will be added later) This draft Indian Standard is identical with ISO 15010:1998 'Disposable hanging devices for transfusion and infusion bottles - Requirements and test methods' issued by the International Organization for Standardization. The text of ISO standard has been approved as suitable for publication as Indian Standard without deviations. Certain conventions are, however, not identical to those used in the Indian Standards. Attention is particularly drawn to the following: a) Wherever the words International Standard appear referring to this standard, they should be read as Indian Standard. b) Comma (,) has been used as a decimal marker while in Indian Standards, the current practice is to use a point (.) as the decimal marker. In this adopted standard, reference appears to certain International Standards for which Indian Standards also exist. The corresponding Indian Standards which are to be substituted in their places are listed below along with their degree of equivalence for the editions indicated: International Standards Corresponding Indian Standards ISO :1987 Transfusion IS :1996 Transfusion equipment for medical use Part 1: equipment for medical use Part Glass transfusion bottles, closures and 1: Glass transfusion bottle, caps closures and caps (first ISO :1989 General tolerances Part 1: Tolerances for linear and angular dimensions without individual tolerance indications revision) IS 2102 (Part1) : 1993 General tolerances Part 1 Tolerances for linear and angular dimensions without individual tolerance indications (third revision) Degree of Equivalence Technical Equivalent Identical