- 밸리데이션 요약 가이드가
ReNu SU Technology cartridges
ReNu SU Technology and its raw materials have been tested under a range of pharmacopoeial and non-pharmacopoeial standards. These include:
- USP Biocompatibility in vivo and in vitro
- European Pharmacopoeia, 3.1.9
- ISO 10993
Additional testing carried out includes extractables testing.
The full validation guide including additional information regarding test methods and actual test reports is available on request.
ReNu SU Technology, its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances are available in the ReNu SU Technology compliance guide.
Both the full validation guide and the compliance guide can be requested by submitting the below form.
Download summary guide
ReNu SU Technology cartridge validation summary guide
밸리데이션 요약 가이드가 PDF - 367kb