GB 10035-2017 Active National standards force_standard

GB 10035-2017 Air-bag type sequential external counter-pulsation device

GB 10035-2017 Air-bag type sequential external counter-pulsation device

Publish Date: 2017-12-29 Implement Date: 2019-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 10035-2017

Standard Type: National standards

Standard Status: Active

is_force_gb: yes

CCS Name: Extracorporeal circulation, artificial organs, and prosthetic devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2017-12-29

Implement Date: 2019-07-01

Pages: 16 pages

Scope

This standard specifies the terms and definitions, classification and structure, requirements, test methods, marking, user manuals, packaging, transportation, and storage.

Development Information

Word Count: 30 Thousand words Pages: 16 pages

Replace the following standards

GB 10035-2006 Air-bag type sequential external counter-pulsation device

Referenced Standards

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 9969-2008 General principles for preparation of instructions for use of industrial products GB 9969.1-1998 General principles for preparation of instructions for use of industrial products GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements YY 0505-2005 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY 0784-2010 Medical electrical equipment—Particular requirements for the basic safety and essential performance of pulse oximeter equipement for medical use GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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GB/T 13461-1992 Synthetic resin blow knee prostheses

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GB/T 14191-1993 Replaced

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