YY/T 0195-1994Test method for reliability of electrocardiogram machine (English PDF)
心电图机可靠性试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 19, 1994
Implementation date
May 1, 1995
Scope
YY/T 0195-1994 is the English-translated version of 心电图机可靠性试验方法.
YY/T 0195-1994 is the recommended Chinese medical device industry standard for reliability testing of electrocardiogram machines. It sets out the laboratory tests by which reliability is verified and measured, so that a reliability characteristic of the product can be assessed or estimated.
The standard treats the electrocardiograph as a repairable product whose life follows an exponential distribution, that is, with a constant failure rate. The characteristic used is the mean life, the mean interval between two consecutive failures, known as the mean time between failures or MTBF.
It applies to single-channel and multi-channel electrocardiogram machines of the various models used in ordinary environments, and it quotes GB 3187, GB 5080.7, GB 9706.1 and GB/T 14710. Issued on 19 December 1994, it has applied since 1 May 1995.
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Document preview — YY/T 0195-1994
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Scope
- Normative references
- About this standard
- Classification and status
1 Foreword
YY/T 0195-1994 was issued by NMPA on 19 December 1994 and has been in force since 1 May 1995.
2 Scope
This standard is the recommended Chinese medical device industry standard for reliability testing of electrocardiogram machines. It sets out the laboratory tests by which reliability is verified and measured, so that a reliability characteristic of the product can be assessed or estimated. The standard treats the electrocardiograph as a repairable product whose life follows an exponential distribution, that is, with a constant failure rate. The characteristic used is the mean life, the mean interval between two consecutive failures, known as the mean time between failures or MTBF. It applies to single-channel and multi-channel electrocardiogram machines of the various models used in ordinary environments, and it quotes GB 3187, GB 5080.7, GB 9706.1 and GB/T 14710.
3 Normative references
YY/T 0195-1994 cites the following standards, which apply in full or in part through the references made to them in its clauses.
GB 3187
GB 5080.7
GB 9706.1
GB/T 14710
4 About this standard
Issued by: NMPA
English translation: about 15 pages
5 Classification and status
Prefix YY/T: recommended standard.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
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Related Standards
GB 9706.1-2020 — Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
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