BS EN ISO 10079-1:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Medical suction equipment Electrically powered suction equipment
Hardcopy , PDF
05-02-2019
English
29-02-2016
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Cleaning, disinfection and sterilization
6 Design requirements
7 Operational requirements
8 Physical requirements for suction equipment
for field use
9 Performance requirements for vacuum level
and flowrate
10 Resistance to environment of suction equipment
for field and/or transport use
11 Information to be supplied by the manufacturer
(labelling and instructions for use)
Annex A (normative) - Test methods
Annex B (informative) - Rationale statement
Annex C (informative) - Lumen size and its effect on flowrate
Annex D (informative) - Schematic of suction equipment
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169]
aimed to be covered
Defines safety and performance requirements for electrically powered medical and surgical suction equipment.
| Committee |
CH/121
|
| DevelopmentNote |
Supersedes 97/565289 DC. (05/2005) Supersedes BS 5724-2.28(2000) & 08/30192512 DC. (04/2009) Supersedes 13/30268585 DC. (12/2015)
|
| DocumentType |
Standard
|
| Pages |
84
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
| Standards | Relationship |
| NS EN ISO 10079-1 : 2015 | Identical |
| ONORM EN ISO 10079-1 : 2016 | Identical |
| ISO 10079-1:2015 | Identical |
| NBN EN ISO 10079-1 : 2015 | Identical |
| EN ISO 10079-1:2015 | Identical |
| NF EN ISO 10079-1 : 2016 | Identical |
| DIN EN ISO 10079-1:2016-05 | Identical |
| NEN EN ISO 10079-1 : 2015 | Identical |
| I.S. EN ISO 10079-1:2015 | Identical |
| UNE-EN ISO 10079-1:2016 | Identical |
| SN EN ISO 10079-1:2016 | Identical |
| UNI EN ISO 10079-1 : 2009 | Identical |
| ISO 8836:2014 | Suction catheters for use in the respiratory tract |
| 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 |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| ISO 10651-4:2002 | Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| ISO 10079-2:2014 | Medical suction equipment Part 2: Manually powered suction equipment |
| IEC 60529:1989+AMD1:1999+AMD2:2013 CSV | Degrees of protection provided by enclosures (IP Code) |
| ISO 10079-3:2014 | Medical suction equipment Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
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.