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YY 9706.108-2021: Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance-Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid
Similar standardsYY 9706.108-2021: Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance-Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical 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/YY9706.108-2021 YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.01 C 30 Replacing YY 0709-2009 Medical Electrical Equipment – Part 1-8.General Requirements for Basic Safety and Essential Performance - Collateral Standard. General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems (IEC 60601-1-8.2006+A1.2012, MOD) Issued on. MARCH 09, 2021 Implemented on. MAY 01, 2023 Issued by. National Medical Products Administration Table of ContentsForeword... 3 1 Scope, Object and Related Standards... 5 2 Normative References... 6 3 Terms and Definitions... 7 4 General Requirements... 12 5 ME EQUIPMENT Identification, Marking and Documents... 12 6 ALARM SYSTEMS... 13 Annex A (Informative) General Guidance and Rationale... 37 Annex B (Informative) Guide to Marking and Labelling Requirements for ME EQUIPMENT and ME SYSTEMS... 87 Annex C (Normative) Symbols on Marking... 90 Annex D (Informative) Guidance for Auditory ALARM SIGNALS... 96 Annex E (Informative) Verbal ALARM SIGNALS... 98 Annex F (Normative) Reserved Melodies for ALARM SIGNALS... 101 Bibliography... 102ForewordAll technical contents (requirements) of this Part are mandatory. The serial standards of Medical Electrical Equipment can be divided into two parts. --- Part 1.General and Collateral Requirements; --- Part 2.Particular Requirements. This Part is Part 1-8. This Part was drafted as per the rules specified in GB/T 1.1-2009. This Part replaced YY 0709-2009 Medical Electrical Equipment - Part 1-8.General Requirements for Safety - Collateral Standard. General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems. Compared with YY 0709-2009, the major technical changes of this Part are as follows besides the editorial modifications. --- Update the structure of this Part according to the standard structure of IEC 60601- 1.2005+A1.2012; --- Add the term "acknowledged" (see 3.37 of this Edition); --- Add the general requirements (see Clause 4 of this Edition); --- Added ME equipment identification, marking and documents (see Clause 5 of this Edition); --- Add the operator adjustable sound pressure level (see 6.3.3.3 of this Edition); --- Add the DISTRIBUTED ALARM SYSTEM intended for confirmed delivery of ALARM CONDITIONS (see 6.11.2.2.1 of this Edition); --- Add the DISTRIBUTED ALARM SYSTEM not intended for confirmed delivery of ALARM CONDITIONS (see 6.11.2.2.2 of this Edition); --- Add the technical requirements for the provision of ME equipment with a global AUDIO OFF in a DISTRIBUTED ALARM SYSTEM (see 6.11.2.2.3 of this Edition); --- Modify the inspection and functional testing methods of the alarm system (see 6.3.3.1 and 6.3.3.2 of this Edition; 201.3.3.1 and 201.3.3.2 of 2009 Edition). This Part adopts the redrafting method to modify and use IEC 60601-1-8.2006+A1.2012 Medical Electrical Equipment – Part 1-8.General Requirements for Basic Safety and Essential Performance – Collateral Standard. General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems (English Version). Compared with IEC 60601-1-8.2006+A1.2012, the major technical differences and editorial modifications of this Part are as follows. --- Regarding the normative references, this Part has made adjustments with technical differences to adapt to the technical conditions of China. The adjustments are reflected in Clause 2 “Normative References”. The specific adjustments are as follows. Use GB/T 3767-2016 that equivalently adopts international standard to replace ISO 3744.2010; Use GB/T 3785.1-2010 that equivalently adopts international standard to replace IEC 61672-1.2002; Use GB 9706.1-2020 that modifies and adopts international standard to replace IEC 60601-1.2005+AMD1.2012; Use YY/T 1474 that modifies and adopts international standard to replace IEC 62366.2007. This Part made the following editorial modifications. --- Add A.3 in Annex A, which gives the corresponding relationship between international standard and current national or industry standard; --- Delete the index. Please note some contents of this Document may involve patents. The issuing agency of this Document shall not assume the responsibility to identify these patents. This Part was proposed by National Medical Products Administration. This Part shall be under the jurisdiction of National Technical Committee on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10). Drafting organizations of this Part. Shanghai Testing & Inspection Institute for Medical Devices; and BMC Medical Co., Ltd. Chief drafting staffs of this Part. He Jun, Chen Xingwen, Chen Bei, Zeng Kejun, Li Zejin, and Ye Shasha. The historical edition replaced by this Part is as follows. --- YY 0709-2009. Medical Electrical Equipment – Part 1-8.General Requirements for Basic Safety and Essential Performance - Collateral Standard. General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems1 Scope, Object and Related StandardsThe object of this Part is to specify BASIC SAFETY and ESSENTIAL PERFORMANCE requirements and tests for ALARM SYSTEMS in ME EQUIPMENT and ME SYSTEMS and to provide guidance for their application. A requirement in a particular standard takes priority over the corresponding requirement in this Part.2 Normative ReferencesThe following documents are essential to the application of this Document. For the dated documents, only the versions with the dates indicated are applicable to this Document; for the undated documents, only the latest version (including all the amendments) is applicable to this Document.3 Terms and DefinitionsFor the purposes of this Document, the terms and definitions given in GB 9706.1-2020 and YY/T 1474, and the following apply.4 General RequirementsIf the MANUFACTURER chooses as a means of RISK CONTROL to have the ME EQUIPMENT or ME SYSTEM notify the OPERATOR that a HAZARDOUS SITUATION can exist, then the ME EQUIPMENT or ME SYSTEM shall include an ALARM SYSTEM complying with this collateral standard for that purpose.5 ME EQUIPMENT Identification, Marking and DocumentsNOTE. Additional requirements on ACCOMPANYING DOCUMENTS are specified in this collateral standard, together with the technical requirements, giving rise to requirements on ACCOMPANYING DOCUMENTS. These requirements are also listed in Table B.2.6 ALARM SYSTEMSWhen applicable, the MANUFACTURER shall address in the RISK MANAGEMENT PROCESS the RISKS associated with verbal ALARM SIGNALS. Compliance is checked by inspection of the RISK MANAGEMENT FILE.Annex A(Informative) General Guidance and Rationale This annex provides a rationale for the important requirements of this collateral standard. Its purpose is to promote effective application of the standard by explaining the reasons for the requirements, providing examples of how they address certain alarm-related HAZARDS and providing additional guidance where appropriate. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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