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YY/T 0708-2009 PDF English

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YY/T 0708-2009: Medical electrical equipment. Part 1-4: General requirements for safety. Collateral standard: Programmable electrical medical systems
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YY/T 0708-2009245 Add to Cart Auto, 9 seconds. Medical electrical equipment. Part 1-4: General requirements for safety. Collateral standard: Programmable electrical medical systems Obsolete

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YY/T 0708-2009: Medical electrical equipment. Part 1-4: General requirements for safety. Collateral standard: Programmable electrical medical systems


---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0708-2009
YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.01 C 30 YY/T 0708-2009 / IEC 60601-1-4.2000 Medical electrical equipment - Part 1-4.General requirements for safety - collateral standard. programmable electrical medical systems (IEC 60601-1-4.2000, IDT) Issued on. NOVEMBER 15, 2009 Implemented on. DECEMBER 01, 2010 Issued by. China Food and Drug Administration

Table of Contents

Foreword... 3 Introduction... 4 SECTION 1.GENERAL... 5 1 Scope of application, object and relationship to other standards... 5 1.201 Scope... 5 1.202 Object... 5 1.203 Relationship to other standards... 6 2.201 Terminology and definitions... 7 2.202 Degrees of requirements and miscellaneous terms... 9 6 Identification, marking and documents... 9 6.8 ACCOMPANYING DOCUMENTS... 9 SECTION 9.ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS... 10 52 Abnormal operation and fault conditions... 10 52.201 Documentation... 10 52.202 RISK management plan... 10 52.203 DEVELOPMENT LIFE-CYCLE... 11 52.204 RISK management process... 14 52.205 Qualification of personnel... 16 52.206 Requirement specification... 17 52.207 Architecture... 17 52.208 Design and implementation... 18 52.209 VERIFICATION... 18 52.210 VALIDATION... 19 52.211 Modification... 19 52.212 Assessment... 20 Annex AAA (Normative) Terminology - Index of defined terms... 21 Annex BBB (Informative) Rationale... 22 Annex CCC (Informative) RISK concepts... 25 Annex DDD (Informative) DEVELOPMENT LIFE-CYCLE... 32 Annex EEE (Informative) Examples for PEMS/PESS structures... 35 Annex FFF (Informative) Bibliography... 37

Foreword

This Collateral Standard is identical to IEC 60601-1-4.2000 “Medical electrical equipment - Part 1-4.General requirements for safety - Collateral Standard. Programmable electrical medical systems”. This Collateral Standard is a Collateral Standard of the General Standard GB 9706.1-2007 “Medical electrical equipment - Part 1.General requirements for safety” (IEC 60601-1.1988, IDT). Annex AAA of this Collateral Standard is a normative annex. Annex BBB, annex CCC, annex DDD, annex EEE, annex FFF are all informative annexes. This Collateral Standard shall be under the jurisdiction of National Technical Committee 10 on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10). Drafting organizations of this Collateral Standard. Hangzhou Center for Medical Device Quality Supervision and Testing of China Food and Drug Administration, National Quality Supervision and Inspection Center of Medical Ultrasonic Equipment. Main drafters of this Collateral Standard. Du Kun, Ma Li, Mang Anshi, Zheng Jian.

1 Scope of application, object and relationship to other standards

A requirement in a Particular Standard takes priority over the corresponding requirement in this Collateral Standard. 2.201 Terminology and definitions For the purpose of this Collateral Standard, the following terminology and definitions apply. In this Collateral Standard, terms printed in CAPITALS are used in accordance with their definitions in the General Standard, GB 9706.15, this Collateral Standard or IEC 60788.1984.

6 Identification, marking and documents

Information pertaining to any specific EQUIPMENT that software is intended to be used in conjunction with, and a means by which the MANUFACTURER can be contacted, can be located on the package or in the INSTRUCTIONS FOR USE so that it is available to the USER independently of the software operation.

52 Abnormal operation and fault conditions

The leader of the team carrying out the VALIDATION shall be independent of the design team. Compliance is checked by inspection of the RISK MANAGEMENT FILE. Annex AAA (Normative) Terminology - Index of defined terms With current technology there is no definitive way to determine what processes are appropriate for any particular case. Users of the standard should use their best judgement, based on what is reasonably practicable and taking account of the ALARP principle. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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