EN 13544-1:2007+A1:2009
Respiratory therapy equipment - Part 1: Nebulizing systems and their components
- Standard No.
- EN 13544-1:2007+A1:2009
- Release Date
- 2009
- Published By
- European Committee for Standardization (CEN)
- Latest
- EN 13544-1:2007+A1:2009
- Replace
- EN 13544-1-2007 EN 13544-1/prA1-2009
- Scope
- The scope given in Clause 1 of EN 60601-1:1990 applies except that 1.1 is replaced by the following: 1.1 This European Standard specifies requirements for nebulizing systems used for the delivery of drugs in an aerosol form to humans through the respiratory system. This European Standard includes gas-powered nebulizers which may be derived from e. g. compressors, pipeline systems, cylinders etc., or electrically-powered nebulizers (e. g. ultrasonic and membrane devices) or manually-powered nebulizers. NOTE Requirements for nebulizers having also a humidification function are specified in EN ISO 8185:1997 + AC:2002 "Humidifiers" (see 56.102). This European Standard does not apply to nebulizers precharged with a specific medicinal product (e. g. MDI, DPI).
EN 13544-1:2007+A1:2009 Referenced Document
- EN 1041:2008 Information supplied by the manufacturer of medical devices
- EN 1281-2:1995 Anaesthetic and Respiratory Equipment - Conical Connectors - Part 2: Screw-Threaded Weight-Bearing Connectors (ISO 5356-2 : 1987 Modified)
- EN 1707:1996 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings
- EN 20594-1:1993 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment; part 1: general requirements (ISO 594-1:1986)
- EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices*， 2024-04-20 Update
- EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices*， 2024-04-20 Update
- EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Incorporating corrigendum March 2010)
- EN 60601-1:1990 Medical Electrical Equipment Part 1: General Requirements for Safety Includes Amendments A1:1993, A11:1993, A12:1993, A2:1995 and A13:1996; Incorporates Corrigendum July 1994; Incorporates Corrigendum August 2005; IEC 60601-1:1988 + A1:1991 + A2:1995 + c
- EN 737-1:1998 Medical Gas Pipeline Systems - Part 1: Terminal Units for Compressed Medical Gases and Vacuum
- EN 739:1998 Low-pressure hose assemblies for use with medical gases Includes Amendment A1: 2002
EN 13544-1:2007+A1:2009 history
- 2009 EN 13544-1:2007+A1:2009 Respiratory therapy equipment - Part 1: Nebulizing systems and their components
- 2007 EN 13544-1:2007 Respiratory therapy equipment - Part 1: Nebulizing systems and their components (Incorporates Amendment A1: 2009)
- 2004 EN 13544-1:2004 Respiratory therapy equipment Part 1: Nebulizing systems and their components (Incorporates Amendment A1: 2004)
- 2001 EN 13544-1:2001 Respiratory Therapy Equipment - Part 1: Nebulizing Systems and Their Components
