Custom Product Evaluation
AATCC
- AATCC - 100
AOAC
ASTM
CLSI
- CLSI M07-A10
USP
- USP - 51
EN
- EN 14476
- EN 14348
- EN 13624
- EN 13727
- EN 12791
- EN 1499
- EN 1500
- EN 13697
- EN 1276
- EN 1275
- EN 1040
- EN 1650
- EN 13726-1
- EN 13726-2
- EN 13726-3
- EN 13726-4
- EP 5.1.3
Custom Designed Methods
- Colony Biofilm Method
EPA Registration
ISO Standards
JIS Standards
- JIS L1902
OECD
- OECD 431
- OECD 437
- OECD 439
- OECD 435
- OECD 492
PCPC
- Personal Care Products Council (PCPC)

ISO 22442-3

Medical devices utilizing animal tissues and their derivatives – Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (December 15, 2007).

BioScience Laboratories provides a scale-down testing per ISO 22442-3 to meet ICH Guideline “Q5A Viral Safety Evaluation of Biotechnology Product Derived From Cell Lines of Human or Animal Origin”. ISO 22442-3 specifies testing requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which is non-viable or has been rendered non-viable.

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Labs

Virology Testing Laboratory

BioScience Laboratories can assist with new product development, R&D projects, and supporting EPA, FDA, EU, and Health Canada label claims. Combining our virology capabili...

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