16/30346835 DC : 0
NA
NA
Status of Standard is Unknown
BS ISO 20789 - ANAESTHETIC AND RESPIRATORY EQUIPMENT - PASSIVE HUMIDIFIERS
Available format(s)
Hardcopy , PDF
Language(s)
English
Publisher
Important note : All end users must be registered with an Account prior to user licenses being assigned.
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for testing
5 General requirements
6 Identification, marking and
ACCOMPANYING DOCUMENTATION
7 HUMIDIFICATION OUTPUT
8 Systems requirements
9 Specific SINGLE FAULT CONDITIONS
10 Cleaning and disinfection
11 BREATHING SYSTEM connectors and ports
12 Requirements for the BREATHING
SYSTEM and ACCESSORIES
13 Compatibility with substances
14 BIOCOMPATIBILITY
15 Requirements for fire prevention
16 USABILITY
Annex A (informative) - Rationale and guidance
Annex B (informative) - Symbols on marking
Annex C (normative) - Determination of
HUMIDIFICATION OUTPUT
Annex D (informative) - Reference to the Essential Principles
Annex E (informative) - Terminology - alphabetized
index of defined terms
Annex ZA (informative) - Relationship between
this document and the Essential Requirements of
EU Directive 93/42/EEC
Bibliography
BS ISO 20789.
| Committee |
CH/121/9
|
| DocumentType |
Draft
|
| Pages |
63
|
| PublisherName |
British Standards Institution
|
| Status |
NA
|
| EN ISO 5367:2014 | Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2014) |
| ISO 80601-2-69:2014 | Medical electrical equipment Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment |
| IEC 60601-2-19:2009+AMD1:2016 CSV | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
| 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 |
| EN 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
| EN ISO 5356-1:2015 | Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015) |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| EN ISO 80369-1:2010 | Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010) |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 5356-1:2015 | Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| 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 80601-2-70:2015 | Medical electrical equipment Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment |
| EN 60601-2-19:2009/A1:2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-19: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF INFANT INCUBATORS (IEC 60601-2-19:2009/A1:2016) |
| EN ISO 9360-2:2009 | Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001) |
| ISO 5367:2014 | Anaesthetic and respiratory equipment — Breathing sets and connectors |
| ISO 80601-2-12:2011 | Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
| ISO 8185:2007 | Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems |
| ISO 14159:2002 | Safety of machinery — Hygiene requirements for the design of machinery |
| ISO 23328-2:2002 | Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects |
| EN 61672-1:2013 | Electroacoustics - Sound level meters - Part 1: Specifications |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 80369-1:2010 | Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements |
| EN ISO 9360-1:2009 | Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000) |
| ISO 9360-1:2000 | Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml |
| ISO 10780:1994 | Stationary source emissions — Measurement of velocity and volume flowrate of gas streams in ducts |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 4135:2001 | Anaesthetic and respiratory equipment Vocabulary |
| ISO 9360-2:2001 | Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml |
| EN ISO 4135:2001 | Anaesthetic and respiratory equipment - Vocabulary (ISO 4135:2001) |
| ISO 10524-1:2006 | Pressure regulators for use with medical gases Part 1: Pressure regulators and pressure regulators with flow-metering devices |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| ISO 594-1:1986 | Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements |
| EN 13544-2:2002+A1:2009 | Respiratory therapy equipment - Part 2: Tubing and connectors |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| PREN 3744 : 200P1 | AEROSPACE SERIES - STRAIGHT PINS, SPRING TYPE, LIGHT DUTY, IN CORROSION RESISTING SPRING STEEL, PASSIVATED |
| EN 60601-1-11:2015 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
| ISO 27427:2013 | Anaesthetic and respiratory equipment — Nebulizing systems and components |
| ISO 7396-1:2016 | Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum |
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.