Customer Support: +44 (0)203 327 3140

Login to i2i Subscription Intertek.com
  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Go to AMERICAS site
Dismiss alert
Please enter a keyword to search
Advanced search

I.S. EN ISO 17510-2:2009

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
Available format(s)

Hardcopy , PDF

Withdrawn date

31-08-2020

Language(s)

English

Published date

11-05-2009

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Information to be supplied by the manufacturer
5 Construction requirements
  5.1 Mask connectors
  5.2 Biocompatibility
  5.3 Protection against rebreathing
  5.4 Cleaning, disinfection and sterilization
  5.5 Breathing during single fault condition
  5.6 Breathing system filter
6 Vibration and noise
Annex A (informative) - Rationale
Annex B (normative) - Exhaust flow test procedure
Annex C (normative) - Resistance to flow (pressure
        drop)
Annex D (normative) - Anti-asphyxia valve pressure
        testing
Annex E (normative) - Breathing during single fault
        condition - Determination of the inspiratory
        and expiratory resistance
Annex F (normative) - CO[2] rebreathing
Annex G (normative) - Vibration and noise
Annex H (informative) - Guide to information to be
        supplied by the manufacturer
Annex I (informative) - Reference to the essential
        principles
Annex J (informative) - Environmental aspects
Annex K (informative) - Terminology - Alphabetized
        index of defined terms
Bibliography
Annex ZA (informative) - Relationship between this
         European Standard and the Essential
         Requirements of EU Directive 93/42/EEC

Applicable to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient.

DocumentType
Standard
Pages
44
PublisherName
National Standards Authority of Ireland
Status
Withdrawn
SupersededBy
Supersedes

ISO 4871:1996 Acoustics — Declaration and verification of noise emission values of machinery and equipment
ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO 17510-1:2007 Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment
ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices

View more information
£64.06
Excluding VAT
GBP
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF - English
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us