GB 16174.1-2015Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (English PDF)

Foreword

This document was drafted in accordance with the rules given in GB/T 1.1-2020,

Directives for standardization - Part 1.Rules for the structure and drafting of

standardizing documents.

This document is Part 1 of GB 16174, Implants for surgery - Active implantable medical

devices. The following parts have been published under GB 16174.

-- Part 1.General requirements for safety, marking and for information to be

provided by the manufacturer;

-- Part 2.Cardiac pacemakers.

This document replaces GB 16174.1-2015 Implants for surgery - Active implantable

medical devices - Part 1.General requirements for safety, marking and for information

to be provided by the manufacturer. Compared with GB 16174.1-2015, in addition to

structural adjustments and editorial changes, the main technical changes are as follows.

-- Change terms and definitions (see Clause 3; Clause 3 of the 2015 edition);

-- Add general requirements for software (see 5.2);

-- Add usability of non-implantable parts (see 5.3);

-- Add data security and protection from harm caused by unauthorized

information tampering (see 5.4);

-- Add general requirements for risk management (see 5.5);

-- Add misconnection of parts of the active implantable medical device (see 5.6);

-- Add requirements for human blood or human plasma, and the authorized

representative from the sales packaging (see 9.12, 9.14);

-- Change the requirements for particle release (see 14.2; 14.2 of the 2015

edition);

-- Change the requirements for electric neutrality (see 16.2; 16.2 of the 2015

edition);

-- Add requirements for active implantable medical device intended to supply

heat (see 17.2);

-- Add requirements for the active implantable medical device that is intended

to use a transcutaneous energy transfer system (see 19.6);

-- Change the requirements for the exposure test to diagnostic levels of

ultrasonic energy (see 22.1; Clause 22 of the 2015 edition);

-- Add requirements for wearing an active implantable medical device for an

MRI procedure (see 22.2);

-- Change the test of the implantable connectors (see 23.6; 23.6 of the 2015

edition);

-- Add the mechanical shock test (see 23.7);

-- Add requirements for accompanying documentation (see 28.24~28.28, 28.30).

This document adopts ISO 14708-1.2014 Implants for surgery - Active implantable

medical devices - Part 1.General requirements for safety, marking and for information

to be provided by the manufacturer by modification.

The technical differences between this document and ISO 14708-1.2014 and their

reasons are as follows.

-- Use the normative reference GB/T 2423.5-2019 to replace IEC 60068-2-

1 Scope

This document specifies requirements that are generally applicable to active

implantable medical devices.

This document is applicable to active implantable medical devices that are electrically

powered and powered by other energy sources (for example by gas pressure or by

springs), as well as to some non-implantable parts and accessories of the active

implantable medical devices.

Note 1.For particular types of active implantable medical devices, these general

requirements are supplemented or modified by the requirements of particular

parts.

The tests that are specified in this document are type tests and are to be carried out on

samples of an active implantable medical device to show compliance.

Note 2.The device that is commonly referred to as an active implantable medical

device can be a single device, a combination of devices, or a combination of

a device or devices and one or more accessories. Not all of these parts are

required to be either partially or totally implantable, but there is a need to

specify some requirements of non-implantable parts and accessories if they

could affect the safety or performance of the implantable device.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this

document and are indispensable for its application. For dated references, only the

edition cited applies. For undated references, the latest edition of the referenced

document (including any amendments) applies.

GB/T 2423.5-2019, Environmental testing - Part 2.Test methods - Test Ea and

guidance. Shock (IEC 60068-2-27.2008, IDT)

GB/T 2423.22-2012, Environmental testing - Part 2.Tests methods - Test N.

Change of temperature (IEC 60068-2-14.2009, IDT)

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