YY/T / ISO :2012

Transcription

1 Translated English of Chinese Standard: YY/T ICS ; C 37 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE S REPUBLIC OF CHINA YY / ISO :2012 Replacing YY Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements 医疗器械用于医疗器械标签 标记和提供信息的符号 第 1 部分 : 通用要求 (ISO :2012, IDT) Issued on: January 26, 2016 Implemented on: January 1, 2017 Issued by: China Food and Drug Administration Page 1 of 33

2 Table of Contents Foreword... 3 Introduction Scope Normative references Terms and definitions General requirements Proposal of symbols for adoption Requirements for usage Other symbols Symbols Manufacture Sterility Storage Safe use IVD-specific Transfusion/infusion Other Annex A (informative) Examples Annex B (informative) Use of general prohibition symbol and negation symbol Bibliography Page 2 of 33

3 Foreword YY/T 0466 consists of the following 2 parts, under the general title Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied : - Part 1: General requirements; - Part 2: Symbol development, selection and validation. This Part is Part 1 of YY/T This Part is drafted according to the rules given in GB/T This Part replaces YY/T Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements. Compared with YY , the main changes are as follows: - MODIFY the introduction; - MODIFY the scope; - MODIFY the normative references; - DELETE 4 terms and definitions, i.e. iconic presentation, symbol concept, symbol original and symbol presentation ; - ADD 12 symbols in Table 1, i.e. Manufacturer, Authorized representative in the European Community, Sterile fluid path, Contains or presence of natural rubber latex, Contains sufficient for <n> tests, For IVD performance evaluation only, Sampling site, Fluid path, Non-pyrogenic, Drops per millilitre, Liquid filter with pore size and One-way valve ; - ADD the column content of description of symbol, requirements, informative notes, restrictions of use and additional requirements; - DELETE Annex B Proposal of using symbols in YY/T and Annex C Basic pattern of symbol design. This Part uses the translation method to equivalently adopt ISO :2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (English version). China s national documents identical or equivalent to the International documents normatively referenced in this Part are as follows: Page 3 of 33

4 - GB/T Graphical symbols for use on equipment - Part 1: Common symbols (ISO 7000:2004, NEQ); - GB/T Data elements and interchange formats - Information interchange - Representation of dates and times (ISO 8601:2000, IDT); - YY/T Medical devices - Application of risk management to medical devices (ISO 14971:2007, IDT); - YY/T Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2: Symbol development, selection and validation (ISO :2010, IDT). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing organizations of this document shall not be held responsible for identifying any or all such patent rights. This Part is proposed by China Food and Drug Administration. This Part is under the jurisdiction of National Technical Committee on Medical Device Quality Management and General Requirements of Standardization Administration of China (SAC/TC 221). Drafting organization of this Part: Beijing Guo Guang Certification of Medical Devices Co., Ltd. Main drafters of this Part: Mi Lanying, Zheng Yihan, Chen Zhigang. The previous editions of the standard replaced by this Part are as follows: - YY , YY/T Page 4 of 33

5 Bibliography [1] ISO Graphical symbols - Safety colours and safety signs - Part 1: Design principles for safety signs and safety markings [2] GB/T Graphical symbols for use on equipment - Index and synopsis (GB/T , ISO 7000:1989 1), IDT) [3] ISO 7010 Graphical symbols - Safety colours and safety signs - Registered safety signs [4] ISO/TR 7239 Development and principles for application of public information symbols 2) [5] ISO Medical devices - Quality management - Medical device nomenclature data structure [6] ISO In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use 3) [7] ISO In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use 4) [8] ISO In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing 5) [9] ISO In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing 6) [10] ISO Basic principles for graphical symbols for use on equipment - Part 2: Form and use of arrows [11] ISO/IEC Collection of graphical symbols for office equipment [12] IEC ISO 7000-DB Graphical symbols for use on equipment 1) Withdrawn. The graphical symbol collections of ISO 7000, ISO 7001 and ISO 7010 are also available online in the ISO webstore. For more information, go to 2) Withdrawn. 3) Cancels and replaces EN 375: ) Cancels and replaces EN 591: ) Cancels and replaces EN 376: ) Cancels and replaces EN 592: Page 32 of 33

6 [13] IEC/TR Graphical symbols for electrical equipment in medical practice [14] YY/T Medical devices - Application of usability engineering to medical devices (YY/T , IEC 62366:2007, IDT) [15] GB/T Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration (GB/T , IEC :2008, IDT) [16] GB/T Basic principles for graphical symbols for use on equipment - Part 3: Guidelines for the application of graphical symbols (GB/T , IEC :2002, IDT) [17] YY/T Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices (YY/T , EN 556-1:2001, IDT) [18] EN 980:2008 Symbols for use in the labelling of medical devices [19] EN 1041 Information supplied by the manufacturer of medical devices [20] GHTF/SG1/N43:2005 Labelling for Medical Devices Available at: END Page 33 of 33