Medical Design Briefs - December 2021 - 34

New Requirements for
Medical Device
Cleaning Validations:
An Overview of ST98
A
s medical devices become more advanced and innovative,
so do the regulations that surround them. This includes
guidance for cleaning validations. Historically, AAMI
TIR30 and other similar documents have offered guidance
for this process1; however, the creation of AAMI ST98
offers a standard for cleaning validations. Where AAMI
TIR30:2011 states what considerations should be made during a
cleaning validation, AAMI ST98 provides more details on those
considerations, including, but not limited to, validation of extraction
methods, extraction efficiency requirements, TOC acceptance
criteria, and justification of sample size.
34
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Medical Design Briefs - December 2021

Table of Contents for the Digital Edition of Medical Design Briefs - December 2021

Medical Design Briefs - December 2021 - Intro
Medical Design Briefs - December 2021 - Cov4
Medical Design Briefs - December 2021 - Cov1a
Medical Design Briefs - December 2021 - Cov1b
Medical Design Briefs - December 2021 - Cov1
Medical Design Briefs - December 2021 - Cov2
Medical Design Briefs - December 2021 - 1
Medical Design Briefs - December 2021 - 2
Medical Design Briefs - December 2021 - 3
Medical Design Briefs - December 2021 - 4
Medical Design Briefs - December 2021 - 5
Medical Design Briefs - December 2021 - 6
Medical Design Briefs - December 2021 - 7
Medical Design Briefs - December 2021 - 8
Medical Design Briefs - December 2021 - 9
Medical Design Briefs - December 2021 - 10
Medical Design Briefs - December 2021 - 11
Medical Design Briefs - December 2021 - 12
Medical Design Briefs - December 2021 - 13
Medical Design Briefs - December 2021 - 14
Medical Design Briefs - December 2021 - 15
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Medical Design Briefs - December 2021 - 18
Medical Design Briefs - December 2021 - 19
Medical Design Briefs - December 2021 - 20
Medical Design Briefs - December 2021 - 21
Medical Design Briefs - December 2021 - 22
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Medical Design Briefs - December 2021 - 24
Medical Design Briefs - December 2021 - 25
Medical Design Briefs - December 2021 - 26
Medical Design Briefs - December 2021 - 27
Medical Design Briefs - December 2021 - 28
Medical Design Briefs - December 2021 - 29
Medical Design Briefs - December 2021 - 30
Medical Design Briefs - December 2021 - 31
Medical Design Briefs - December 2021 - 32
Medical Design Briefs - December 2021 - 33
Medical Design Briefs - December 2021 - 34
Medical Design Briefs - December 2021 - 35
Medical Design Briefs - December 2021 - 36
Medical Design Briefs - December 2021 - 37
Medical Design Briefs - December 2021 - 38
Medical Design Briefs - December 2021 - 39
Medical Design Briefs - December 2021 - 40
Medical Design Briefs - December 2021 - 41
Medical Design Briefs - December 2021 - 42
Medical Design Briefs - December 2021 - 43
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Medical Design Briefs - December 2021 - 45
Medical Design Briefs - December 2021 - 46
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Medical Design Briefs - December 2021 - 48
Medical Design Briefs - December 2021 - 49
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Medical Design Briefs - December 2021 - 56
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Medical Design Briefs - December 2021 - 58
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Medical Design Briefs - December 2021 - Cov3
Medical Design Briefs - December 2021 - Cov4
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