ISO/TR 80002-2:2017

Status : Published

	Format	Language
std 1 208	PDF
std 2 208	Paper

CHF208

Convert Swiss francs (CHF) to your currency

Abstract

ISO/TR 80002-2:2017 applies to any software used in device design, testing, component acceptance, manufacturing, labelling, packaging, distribution and complaint handling or to automate any other aspect of a medical device quality system as described in ISO 13485.

ISO/TR 80002-2:2017 applies to

- software used in the quality management system,

- software used in production and service provision, and

- software used for the monitoring and measurement of requirements.

It does not apply to

- software used as a component, part or accessory of a medical device, or

- software that is itself a medical device.

General information

Status
: Published

Publication date
: 2017-06

Stage
: International Standard published [60.60]
Edition
: 1

Number of pages
: 84
Technical Committee :
ISO/TC 210

ICS :
11.040.01 35.240.80
RSS updates