Need help?

EN ISO 17510-1:2009 Standard

wave
Save  

  Keywords:

#use #part #intended #therapy #breathing

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

  Purpose

This part of ISO 17510 specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions. This part of ISO 17510 applies to equipment intended for use with adults and children, and excludes equipment intended for use with neonates. Jet and very high frequency ventilation and oscillation are not considered in this part of ISO 17510.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 17510-1:2007"

Anyway is still possible use the "EN ISO 17510-1:2007" until March 21st, 2010

  Related Standards

EN ISO 10555-1:2009

Medical devices Directive (93/42/EEC)

Sterile, single-use intravascular catheters - Part 1: General requirements (ISO 10555-1:1995, including Amd 1:1999 and Amd 2:2004)

EN 556-1:2001

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN ISO 14155:2020

Medical devices Directive (93/42/EEC)

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

EN ISO 14607:2018

Medical devices Directive (93/42/EEC)

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)

EN ISO 22442-1:2020

Medical devices Directive (93/42/EEC)

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020)

EN ISO 22442-2:2020

Medical devices Directive (93/42/EEC)

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-...

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 17510-1:2009 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0