YY/T 1473-2016 in English

SUPERSEDED

Guide to the development and inclusion of safety aspects in Standards for medical devices

Issued on:2016-01-26
Implemented on:2017-01-01
File Format:PDF
Delivery:Via email within 5 business days

Price(USD)： $320.00
$311.00

Standard No:	YY/T 1473-2016
Document status:	SUPERSEDED
Superseded by:	YY/T 1473-2023 Guide for standardization for medical devices―Inclusion of safety aspects in the development of standards
Superseded on:	2024-01-15
Title in English:	Guide to the development and inclusion of safety aspects in Standards for medical devices
Title in Chinese:	医疗器械标准化工作指南涉及安全要求的标准制定
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 5 business days
Issued on:	2016-01-26
Implemented on:	2017-01-01
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	YY-Pharmaceutics
Related Keywords:	medical device safety standards safety aspects standards writers safety requirements medical devices scopethis standard
Related Topics:	Involved in formulating Medical working frequency band Standard setting work helps standard setting Standardization preparation Standardized work preparation Test standardization and its role Medical device noise standard requirements Standard requirements for fully automatic oxygen index measuring instruments Suture strength test standard medical equipment National standards and industries involving biosafety Standardization requirements for work station equipment Full battery production standardization Requirements for setting quality inspection standards Safety standard requirements for aging houses Standardized Guidelines for Forklift Operation Safety What are the standards involved in biomass gasification? Standards and regulations for heavy metal content in medical devices Seat belts involved Fluorescence standard requirements for medical devices Standardized requirement flow Internal standard quantitative standard curve production

本标准规定了医疗器械安全标准制定过程的要求并提供了指南。
本标准适用于医疗器械标准起草时分析、确定标准中涉及的风险。

Scope

This standard provides guidance for standards writers on how to include safety requirements in the development of medical device safety standards, which are expected to use the risk management framework established in ISO 14971. This guide covers safety-related performance and usability, extending concepts already developed in ISO/IEC Guide 51. This standard is intended for use in conjunction with ISO/IEC Guide 51 and ISO 14971.

More samples: DL/T 368-2010 JGJ 94-2008 DL/T 5154-2012

Sample only — not a preview of YY/T 1473-2016

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