| 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 |
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