Home | About us | Contact us | Sitemap | Checkout | Log In



For information regarding these standards, please contact your SIMCOM representative at
+1 (404) 895-3100 or service@esimcom.com.

Reference Title of Standard Price Buy One Now Add One To Basket
EN 550:1994 Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization $98.00
EN 552:1994 Sterilization of medical devices - Validation and routine control of sterilization by irradiation $95.00
EN 554:1994 Sterilization of medical devices - Validation and routine control of sterilization by moist heat $98.00
EN 556-1:2001 Sterilization of medical devices - requirements for medical devices to be designated "STERILE"- Part1: Requirements for terminally sterilized medical devices "Sterile" $97.00
EN 556-2:2003 Sterilization of medical devices - requirements for medical devices to be designated "STERILE"- Part2: Requirements for aseptically processed medical devices "Sterile" $97.00
EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized - Part 1 : general requirements and test methods $95.00
EN 980:2003 Graphical symbols for use in the labeling of medical devices

Amendment 1 to EN 980
$118.00
EN 1041:1998 Information supplied by the manufacturer with medical devices $98.00
EN 1174-1:1996 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 1 : requirements $98.00
EN 1174-2:1996 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 2 : guidance $70.00
EN 1174-3:1996 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Part 3 : guide to the methods for validation of microbiological techniques $70.00
EN/ ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003) $118.00
EN/ ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Evaluation and testing (ISO 10993-4:2002) $222.00
EN/ ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999) $98.00
EN/ ISO 10993-9:1999 Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999) $98.00
EN/ ISO 10993-10:2002 Biological evaluation of medical devices - Part 10 : tests for irritation and sensitization (ISO 10993-10:2002) $235.00
EN/ ISO 10993-11:1995 Biological evaluation of medical devices - Part 11 : Tests for systemic toxicity (ISO 10993-12:1993) $118.00
EN/ ISO 10993-12:2004 Biological evaluation of medical devices - Part 12 : sample preparation and reference materials (ISO 10993-12:2002) $170.00
EN/ ISO 10993-13:1998 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices (ISO 10993-13:1998) $70.00
EN/ ISO 10993-16:1997 Biological evaluation of medical devices Part 16: toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997) $70.00
EN/ ISO 10993-17:2002 Biological evaluation of medical devices Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002) $194.00
EN/ ISO 10993-18:2005 Biological evaluation of medical devices Part 18: Chemical characterization of materials (ISO 10993-18:2005) $170.00
EN/ ISO 11140-1:2005 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005) $194.00
EN/ ISO 13485:2003 Medical devices- Quality managment systems - Requirements for regulatory purposes (ISO 13485:2003) $170.00
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements 235.00
EN/ ISO 14155-1:2003 Clinical investigation of medical devices for human subjects - Part 1: General requirements (ISO 14155-1:2003) $170.00
EN/ ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation of plans (ISO 14155-2:2003) $118.00
EN/ ISO 14971:2000 Medical devices - Application of risk managment to medical devices (ISO 14971:2000)
EN ISO 14971:2000/A1:2003
$97.00
EN 30993-9:1994 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:1994) $98.00
EN 45502-1:1997 Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer $130.00
EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices inteded to treat bradyarrhythmia (cardiac pacemakers) $263.00
EN 46003:1999 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9003 $70.00
EN 60601-1:1990 Medical electrical equipment. Part 1: General requirements for safety - IEC 601-1:1988

Amendment A1 to EN 60601-1
Amendment A2 to EN 60601-1
Amendment A13 to EN 60601-1
$317.00