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Position: Chinese Standard in English/YY/T 1437-2023
YY/T 1437-2023   Medical devices-Guidance on the application of GB/T 42062 (English Version)
Standard No.: YY/T 1437-2023 Status:valid remind me the status change

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Target Language:English File Format:PDF
Word Count: 37500 words Translation Price(USD):1125.0 remind me the price change

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Implemented on:2024-7-1 Delivery: via email in 1~5 business day

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Standard No.: YY/T 1437-2023
English Name: Medical devices-Guidance on the application of GB/T 42062
Chinese Name: 医疗器械 GB/T 42062应用指南
Chinese Classification: C30    Medical apparatus and devices in general
Professional Classification: YY    Professional Standard - Pharmaceutics
ICS Classification: 11.040.01 11.040.01    Medical equipment in general 11.040.01
Source Content Issued by: National Medical Products Adminstration
Issued on: 2023-06-20
Implemented on: 2024-7-1
Status: valid
Superseding:YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971
Target Language: English
File Format: PDF
Word Count: 37500 words
Translation Price(USD): 1125.0
Delivery: via email in 1~5 business day
本文件提供了按照GB/T 42062-2022开发、实施和保持医疗器械风险管理系统的指南。
风险管理过程可以是质量管理体系(例如基于GB/T 42061-2022的体系)的组成部分,但在GB/T 42062-2022中并无此要求。
GB/T 42061-2022中与风险管理有关的某些要求(第7章“产品实现”和8.2.1“反馈”),能通过应用GB/T 42062-2022来实现,见YY/T 0595-2020。
Code of China
Standard
YY/T 1437-2023  Medical devices-Guidance on the application of GB/T 42062 (English Version)
Standard No.YY/T 1437-2023
Statusvalid
LanguageEnglish
File FormatPDF
Word Count37500 words
Price(USD)1125.0
Implemented on2024-7-1
Deliveryvia email in 1~5 business day
Detail of YY/T 1437-2023
Standard No.
YY/T 1437-2023
English Name
Medical devices-Guidance on the application of GB/T 42062
Chinese Name
医疗器械 GB/T 42062应用指南
Chinese Classification
C30
Professional Classification
YY
ICS Classification
Issued by
National Medical Products Adminstration
Issued on
2023-06-20
Implemented on
2024-7-1
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971
Language
English
File Format
PDF
Word Count
37500 words
Price(USD)
1125.0
Keywords
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Introduction of YY/T 1437-2023
本文件提供了按照GB/T 42062-2022开发、实施和保持医疗器械风险管理系统的指南。
风险管理过程可以是质量管理体系(例如基于GB/T 42061-2022的体系)的组成部分,但在GB/T 42062-2022中并无此要求。
GB/T 42061-2022中与风险管理有关的某些要求(第7章“产品实现”和8.2.1“反馈”),能通过应用GB/T 42062-2022来实现,见YY/T 0595-2020。
Contents of YY/T 1437-2023
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