Type of

deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

1. EN ISO Formatted: Indent: Left: 0", Hanging: 0.17", Space

14971:2012ISO After: 0 pt, Line spacing: single
1. Scope
14971: 2007
Medical Devices - 2. Terms and definitions
Second Edition
Application Of Risk 3. General requirements for risk
2007-03-01,
Management To management
Medical Devices. 4. Risk analysis
Recognition No.
(General I 5. Risk evaluation YES TO ALL - - -
5-4014971 Formatted: Font: +Body (Calibri), 10 pt
(QS/RM))Medical 6. Risk control
Second Edition
devices - Application 7. Evaluation of overall residual risk
2007-03-01
of risk management to acceptability
medical devices 8. Risk management report Formatted: Font color: Auto
1. Recognitio
8.
n No. Formatted: Font: 10 pt, Font color: Black
5-40
Formatted: List Paragraph, Indent: Left: -0.01", Space
Sampling Procedures 1. Scope After: 0 pt, Line spacing: single, Numbered + Level: 1 +
For Inspection By 2. Normative reference Numbering Style: 1, 2, 3, + Start at: 1 + Alignment:
Attributes - Part 1: 3. Terms and definitions Left + Aligned at: 0.25" + Indent at: 0.5"
Sampling Schemes 4. Expression of nonconformity
Fractional
2. ISO 2859- Indexed By Acceptance 5. Acceptance quality limit(AQL) Formatted: Indent: Left: 0", Hanging: 0.17", Space
YES TO acceptance is
1:1999/Cor Quality Limit (Aql) For 6. Submission of product for sampling After: 0 pt, Line spacing: single
SECTIONS 1- - We do not optional and not
1:2001 Lot-By-Lot Inspection 7. Acceptance and non-acceptance
12 use conducted due to
-11-15 [Including: Technical 8. Drawing of samples
fractional insufficient
2. Corrigendum 1 (2001), 9. Normal, tightened and reduced
SECTION 13 : EXCLUSION plants. worker
Recognition No. Amendment 1 (2011)]. 3. inspection
NA training on this
5-4688 (General I 4. Sampling plan
method.
(QS/RM))Sampling 5. Determination of acceptability
Procedures for 6. Further information
Inspection by 7. .Fractional acceptance number
Attributes-Part plans for single sampling (optional)
 Type of
deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

1 : Sampling plans
indexed by
Acceptable Quality
Level (AQL) for lot-by-
lot inspection

Standard Guide For

1. Scope
Accelerated Aging Of
2. Referenced Documents
3. ASTM F1980- Sterile Barrier Systems Formatted: Space After: 0 pt, Line spacing: single
3. Terminology
1607 For Medical Devices.
4. Significance and Use
(Reapproved (Sterility)Standard
5. Apparatus
2011) Guide for YES TO ALL - - -
6. Accelerated Aging Theory
Accelerated Aging of
7. Accelerated Aging Plan
Recognition No. Sterile
8. Post-Aging Testing Guidance
14-229497 Barrier Systems for
9. Report
Medical
10. Keywords
Devices.
4. EN ISO 11607- Packaging For 1. Scope Formatted: Indent: Left: 0", Hanging: 0.17", Space
1:2009, Terminally Sterilized 2. Normative references YES TO ALL - - - After: 0 pt, Line spacing: single
first Medical Devices - Part 3. Terms and definitions
 Type of
deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

edition 2006-04- 1: Requirements For 4. General requirements

15 Materials, Sterile 5. Materials and preformed sterile
Barrier Systems And 4. barrier systems
4. Recognitio Packaging Systems 5. Design and development
n No. 14-43545 [Including: 6. requirements for packaging
Amendment 1 (2014)]. systems
(Sterility)Packaging for 7. Information to be provided
terminally sterilized
medical devices Part
I : Requirements for
materials, sterile
barrier systems and
packaging systems
Packaging For
Terminally Sterilized
Medical Devices - Part
2: Validation
5. EN ISO 11607-2 1. Scope Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
Requirements For
First Edition 2. Normative references spacing: single
Forming, Sealing And
2006-04-15 3. Terms and definitions
Assembly Processes
4. General requirements Formatted: Indent: Left: 0.23", Space After: 0 pt, Line
[Including:
5. 11607- 5. Validation of packaging process YES TO ALL - - - spacing: single, No bullets or numbering
Amendment 1 (2014)].
2:2006, 6. Packaging system assembly
(Sterility)Packaging for
Recognition 7. Use of reusable sterile barrier
terminally sterilized
No. systems
medical devices- Part 2
14-194455 8. Sterile fluid-path packaging
Validation
requirements for
forming, sealing and
assembly processes
 Type of
deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

Sterilization Of Health
Care Products -
Radiation - Part 1:
Requirements For 1. Scope
Development, 2. Normative reference
Validation And Routine 3. Terms and definitions
Control Of A 4. Quality management system
6. EN ISO 11137-1 Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
Sterilization Process elements
First Edition spacing: single
For Medical Devices 5. Sterilizing agent characterization
2006-04-
[Including: 6. Process and equipment
15:2015 YES TO ALL - - -
Amendment 1 (2013)]. characterization
(Sterility)Sterilization 7. Product definition
Recognition
of health care products 8. Process definition
No. 14-297428
Radiation- Part 1: 9. Validation
Requirements for 10. Routine monitoring and control
development, 11. Product release from sterilization
validation, and routine 12. Maintaining process effective
control of a
sterilization process
for medical devices.
7. EN ISO 11137- Sterilization Of Health 1. Scope Formatted: List Paragraph, Indent: Left: 0", Hanging:
2:20135 Care Products - 2. Normative reference 0.2", Space After: 0 pt, Line spacing: single, Numbered
Radiation - Part 2: 3. Abbreviations, terms and + Level: 1 + Numbering Style: 1, 2, 3, + Start at: 4 +
Establishing The definitions Alignment: Left + Aligned at: 0.25" + Indent at: 0.5"
Sterilization Dose. 4. Definition and maintenance of YES TO ALL - - - Formatted: Font color: Black
(Sterility)Sterilization product families for dose setting,
Formatted: List Paragraph, Indent: Left: 0.2", Space
11137-2 Third of health care dose substantiation and
After: 0 pt, Line spacing: single
Edition 2013- products- Radiation- sterilization dose auditing
06-01 Part 2: 5. Select and testing of product for Formatted: Font: (Default) +Body (Calibri), 10 pt, Font
color: Auto
 Type of
deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

Establishing the establishing and verifying the Formatted: Indent: Left: 0.5", Space After: 0 pt, Line
Recognition No. sterilization dose. sterilization dose spacing: single, No bullets or numbering
14-40911137-2 6. Methods of dose establishment
Formatted: Font: +Body (Calibri), 10 pt
Third Edition 7. Method 1 : dose setting using
2013-06-01 (14- bioburden information
409) ?? 8. Method 2 : Dose setting using
fraction positive information from
11137-2:2013 incremental dosing to determine Formatted: Font: 10 pt, Font color: Black
(14-438) ?? and extrapolation factor
9. Method VDmax-Substantiation of Commented [JO1]: Both are recognized by FDA. There is
7. no 2015 version on FDA website
Recognition 25 kGy or 15 kGy as the sterilization
No. 14-225 dose Formatted: Font: 10 pt, Font color: Black
10. Auditing sterilization dose
11. Worked examples
1. Scope
Sterilization Of Health
2. Normative references
Care Products -
3. Terms and definitions
8. AAMI / ANSI / Radiation - Part 3: Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
4. Measurement of dose
ISO 11137- Guidance On spacing: single
5. Selection and calibration of
3:2006/(R)201 Dosimetric Aspects.
dosimetry systems
0EN ISO 11137- (Sterility)Sterilization
6. Establishing the maximum YES TO ALL - - -
3:2006 of health care
acceptable dose
products- Radiation-
7. Establishing the sterilization dose
Recognition Part 3:
8. Installation qualification
No. 14-298 Guidance on
9. Operation qualification
dosimetric
10. Performance qualification
aspects.
11. Routine monitoring and control
9. 9. EN ISO 7886- Sterile Hypodermic 1. Scope Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
YES TO ALL - - -
1 First Edition Syringes For Single Use 2. Normative references spacing: single
 Type of
deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

1993-10- - Part 1: Syringes For 3. Definitions

017886- Manual Use [Including: 4. Nomenclature
1:1997, Technical Corrigendum 5. Cleanliness
1 (1995)]. (General 6. Limits for acidity or alkalinity
Plastic 7. Limits for extractable metals
9. Recognitio Surgery/General 8. Lubricant Formatted: Indent: Left: 0.23", Space After: 0 pt, Line
n No. 6-170304 Hospital)Sterile 9. Tolerance on graduated capacity spacing: single, No bullets or numbering
hypodermic syringe for 10. Graduated scale
single use-Part 1: 11. Barrel
Syringe for manual use 12. Piston/plunger assembly
13. Nozzle
14. Performance
15. Packaging
16. Labeling
Conical Fittings with a
6%(Luer) Taper for
10. ISO 594-1 First
Syringes, Needles and
Edition: 1986- 1. Scope
Certain Other Medical
06-15 2. Normative reference
Equipment Part 1:
10. 3. Dimension and tolerances YES TO ALL - - - Formatted: Indent: Left: 0.23", Space After: 0 pt, Line
General Requirements.
Recognition 4. Requirements spacing: single, No bullets or numbering
(General Plastic
No. 5. Test methods
Surgery/General
6-11
Hospital)Part 1 :
General Requirements
11. ISO 594-2 Conical Fittings With A 1. Scope Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
Second Edition 6% (Luer) Taper For 2. Normative reference spacing: single
1998-09- Syringes, Needles And 3. Dimension and tolerances YES TO ALL - - -
01:1998 Certain Other Medical 4. Requirements
Equipment - Part 2: 5. Test methods
 Type of
deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

Recognition Lock Fittings. (General

No. Plastic
6-129 Surgery/General
Hospital)Conical
Fittings with a
6%(Luer) Taper for
Syringes, Needles and
Certain Other Medical
Equipment Part 2 :
Lock Fittings
Sterilization Of Health
Care Products -
1. Scope
Microbiological
2. Normative references
Methods - Part 1:
3. Terms & definitions
Determination Of The
4. Quality Management system elements
12. AAMI / ANSI / Population Of Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
5. Selection of product
ISO EN ISO Microorganisms On spacing: single
6. Methods of determination and microbial
11737-1:2006 Product.
characteristics of bioburden YES TO ALL - - -
(R)2011, (Sterility)Sterilization
7. Validation of method for determining
of medical devices --
bioburden
Recognition Microbiological
8. Routine determination of bioburden and
No. 14-227 methods -- Part 1:
interpretation of data
Determination of a
9. Maintenance of the method of
population of
determination of bioburden
microorganisms
on products
13. USP 39- 1. Media membrane The device is not Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
NF34:2016USP <71> Sterility tests 2. Alternative Thioglycolate Medium YES TO ALL Option filtration or a spacing: single
34 :2011 <71> 3. Soybean-Casein Digest Medium direct solution. It is
 Type of
deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

4. Media for Penicilins or Cephalosporins inoculation semi-rigid

5. Suitability test which can be cut
13. Recognitio 6. Sterility test into Formatted: Indent: Left: 0.23", Space After: 0 pt, Line
n No. 14- 7. Growth Promotion Test of Aerobes, small pieces and spacing: single, No bullets or numbering
316486 8. Anaeropes and Fungi Storage suitable
9. Diluting and Rinsing Fluids for for the method
Membrane Filtration of direct
inoculation.
1. Apparatus and glassware
2. Preparation of the standard endotoxin
14. USP 39- stock solution and standard solutions Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
We choose to use
NF34:201634:2 3. Preparatory testing spacing: single
Yes to all EXCLUSION Gel-clot
011 <85> <85> Bacterial 4. Preparation of Sample Solutions
except of techniques
Endotoxins test 5. Determination of maximum valid
section 8 section 8 for LAL routine
Recognition dilution (MVD)
test for every lot.
No. 14-317487 6. Establishment of endotoxin limits
7. Gel-clot techniques
8. Photometer techniques
<88> Biological
Reactivity Tests, In
15. USP 39- Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
Vivo, Procedure
NF34:201633- spacing: single
Preparation Of
NF28 Biological
Sample. 1. Test animal
Tests <88> YES TO ALL - - -
(Biocompatibility)Biolo 2. Procedure
gical Reactivity Test, In
15. Recognitio Formatted: Indent: Left: 0.23", Space After: 0 pt, Line
Vitro, Classification of
n No. 2-187231 spacing: single, No bullets or numbering
Plastics --
Intracutaneous Test
 Type of
deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

1. Apparatus and diluents

2. Temperature recording
16. USP 39- Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
3. Test animals
NF34:2016USP spacing: single
<151> Pyrogen Test 4. Procedure
34:2011 <151>
(USP Rabbit Test). 5. Test interpretation and Formatted Table
YES TO ALL - - -
(Biocompatibility)Pyro Continuation
Recognition
gen ( Rabbit ) test 6. Radioactive pharmaceuticals
No. 14-3182-
7. Test Dose for Pharmaceutical
232
Constituents or Reagents to Be Labeled

ISO 6009 Fourth

Edition 2016-08-01,
17. EN ISO Hypodermic Needles Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
6009:2016 For Single Use - Colour spacing: single
Fourth Edition Coding For
1. Scope
2016-08-01 Identification. .
2. Terms and definitions YES TO ALL - - - Formatted: Space After: 0 pt, Line spacing: single
(General Plastic
3. Color code
17. Recognitio Surgery/General Formatted: Indent: Left: 0.23", Space After: 0 pt, Line
n Number 6- Hospital)Hypodermic spacing: single, No bullets or numbering
381 needles for single use -
Colour coding for
identification
18. EN ISO Sterile Hypodermic Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
1. Scope
7864:2016 Needles For Single Use spacing: single
2. Normative references
Fourth Edition - Requirements And
3. Terms and definitions
2016-08-01 Test Methods. YES TO ALL - - -
4. Packaging
(General Plastic Formatted: Indent: Left: 0.23", Space After: 0 pt, Line
5. Information supplied by the
18. Recognitio Surgery/General spacing: single, No bullets or numbering
manufacturer
n Number 6- Hospital)Sterile
 Type of
deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

379 hypodermic needles

for single use -
Requirements and test
methods
Stainless Steel Needle
Tubing For The
Manufacture Of
19. EN ISO Medical Devices - Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
9626:2016 Requirements And spacing: single
1. Scope
Second Edition Test Methods.
2. Normative references
2016-08-01 (General Plastic
3. Terms and definitions YES TO ALL - - -
Surgery/General
4. Materials Formatted: Normal, Space After: 0 pt, Line spacing:
19. Recognitio Hospital)Stainless steel single, No bullets or numbering
5. Requirements
n Number 6- needle tubing for the
Formatted: Normal, Indent: Left: 0.23", Space After: 0
380 manufacture of
pt, Line spacing: single, No bullets or numbering
medical devices -
Requirements and test Formatted: Font: 10 pt, Font color: Black
methods
Medical Devices -
Symbols To Be Used
20. ISO 15223- Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
With Medical Device
1:2016 Second spacing: single
Labels, Labelling, And
Edition 2012- 1. Scope
Information To Be
07-01 2. Normative references
Supplied - Part 1: YES TO ALL - - -
3. Terms and definitions
General Requirements. Formatted: Normal, Indent: Left: 0.23", Space After: 0
Recognition
(General I pt, Line spacing: single, No bullets or numbering
Number 5-90
(QS/RM))Medical Formatted: Font: 10 pt, Font color: Black
20. devices - Symbols to
be used with medical Formatted: Normal, Space After: 0 pt, Line spacing:
single, No bullets or numbering
 Type of
deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

device labels, labelling

and information to be
supplied - Part 1:
General requirements
Biological Evaluation
1. Scope
Of Medical Devices -
2. Normative references
21. AAMI / ANSI / Part 1: Evaluation And Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
3. Terms and definitions
ISO EN ISO Testing Within A Risk spacing: single
4. General principles applying to biological
10993-1:2009 Management Process.
evaluation of medical devices Formatted: Normal, Space After: 0 pt, Line spacing:
/(R)2013 (Biocompatibility) YES TO ALL - - -
5. Categorization of medical devices single, No bullets or numbering
Biological evaluation of
6. Biological evaluation process
21. Recognitio medical devices - Part
7. Interpretation of biological evaluation Formatted: Normal, Indent: Left: 0.17", Space After: 0
n Number 2-156 1: Evaluation and
data and overall biological safety pt, Line spacing: single, No bullets or numbering
testing within a risk
assessment Formatted: Font: 10 pt, Font color: Black
management process
Biological Evaluation Formatted: Font: 10 pt
22. EN ISO 10993- Of Medical Devices -
4:20029 Formatted: Normal, Space After: 0 pt, Line spacing:
Part 4: Selection Of single, No bullets or numbering
1. Scope
Tests For Interaction
10993-4 Second 2. Normative references Formatted: Font: +Body (Calibri), 10 pt
Edition 2002- With Blood [Including: 3. Terms and definitions
Amendment 1 (2006) YES TO ALL - - - Formatted: Normal, Indent: Left: 0.2", Space After: 0
10-15 4. Abbreviated terms
Biological evaluation of pt, Line spacing: single, No bullets or numbering
5. Types of device in contact with blood
22. Recognitio medical devices - Part 6. Characterization of blood interactions Formatted: Normal, Space After: 0 pt, Line spacing:
n Number 2- 4: Selection of tests for single, No bullets or numbering
235- NA interactions with blood Formatted: Normal, Indent: Left: 0.17", Space After: 0
pt, Line spacing: single, No bullets or numbering
Biological Evaluation 1. Scope
23. AAMI / ANSI /
Of Medical Devices - 2. Normative references YES TO ALL - - - Formatted: Font: +Body (Calibri), 10 pt
ISO ISO 10993-
Part 5: Tests For In 3. Terms and definitions Formatted: Font: 10 pt, Font color: Black
 Type of
deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

5:2009 Vitro Cytotoxicity. 4. Sample and control preparation

/(R)2014 (Biocompatibility) 5. Cell lines Formatted: Font: +Body (Calibri), 10 pt
Biological evaluation of 6. Culture medium
medical devices - Part 7. Preparation of cell stock culture Formatted: Pattern: Clear
23. Recognitio
n Number 2- 5: Tests for in vitro 8. Test procedures Formatted: Indent: Left: 0.23", Space After: 0 pt, Line
153 cytotoxicity 9. Test report spacing: single, No bullets or numbering
10. Assessment of results
24. EN ISO 10993- Biological Evaluation Formatted: Font: 10 pt
Of Medical Devices - 1. Scope
10:20103
2. Normative references Formatted: Normal, Space After: 0 pt, Line spacing:
Part 10: Tests For
3. Terms and definitions single, No bullets or numbering
10993-10 Third Irritation And Skin
4. General principles step wise approach
Edition 2010- SensitizationBiological Formatted: Font: +Body (Calibri), 10 pt
08-01
5. Pretest considerations YES TO ALL - - -
evaluation of medical 6. Irritation tests Formatted: Normal, Indent: Left: 0.2", Space After: 0
devices - Part 10: Tests 7. Skin sensitization tests pt, Line spacing: single, No bullets or numbering
24. Recognitio for irritation and skin 8. Key factors in interpretation of test Formatted: Normal, Space After: 0 pt, Line spacing:
n Numbero. 2-
sensitization results single, No bullets or numbering
174- NA
1. Scope Formatted: Normal, Indent: Left: 0.23", Space After: 0
2. Normative references pt, Line spacing: single, No bullets or numbering
3. Terms and definitions Formatted: Font: +Body (Calibri), 10 pt
Sterilization of health
4. Definition and maintenance of product
25. ISO/TS care product - Formatted: Font: 10 pt, Font color: Black
families for sterilization dose
13004:2013 Radiation -
substantiation and sterilization dose Formatted Table
Substantiation of YES TO ALL
auditing
25. Recognitio selected sterilization
5. Selection and testing of product for Formatted: Normal, Space After: 0 pt, Line spacing:
n Number - NA dose: Method
substantiating and auditing a selected single, No bullets or numbering
VDmaxSD
sterilization dose Formatted: Normal, Indent: Left: 0.23", Space After: 0
6. Method VD max SD substantiation of pt, Line spacing: single, No bullets or numbering
a selected sterilization dose of 17.5, 20,
Formatted: Font: 10 pt, Font color: Black
 Type of
deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

22.5, 27.5, 30, 32.5, or 35 kGy

7. Maintaining process effectiveness
8. Tables of value for SIP equal to 1.0 VD
max SD, SIP dose reduction factor and
augmentation dose corresponding to
applicable values of average bioburden
for selected sterilization doses of 17.5,
20, 22.5, 27.5, 30, 32.5 and 35 kGy
9. Worked examples
Packaging For Formatted: Space After: 0 pt, Line spacing: single
Terminally Sterilized
Medical Devices -
Guidance On The
26. ISO/TS Formatted: Indent: Left: -0.02", Space After: 0 pt, Line
Application Of ISO
16775:2014 spacing: single
11607-1 And ISO 1. Scope
First Edition
11607-2. 2. Terms and definitions
2014-05-15
(Sterility)Packaging for 3. Guidance for health care facilities
terminally sterilized 4. Guidance for industry Formatted: Normal, Space After: 0 pt, Line spacing:
26. Recognitio single, No bullets or numbering
medical devices
n Number 14-456
Guidance on the Formatted: Font: 10 pt, Font color: Black
application of ISO
11507 and ISO 11607-
2
27. AAMI / ANSI / Biological Evaluation 1. Scope
ISO EN ISO Of Medical Devices - 2. Normative references
10993-11: Part 11: Tests For 3. Terms and definitions
YES TO ALL - - - Formatted: Default Paragraph Font, Font: (Default)
:2006/(R)2010 Systemic Toxicity. 4. General considerations
+Body (Calibri), 10 pt, Font color: Auto, Pattern: Clear
2009 (Biocompatibility)Biolo 5. Acute systemic toxicity
gical evaluation of 6. Repeated exposure systemic toxicity Formatted: Normal, Space After: 0 pt, Line spacing:
single, No bullets or numbering
 Type of
deviation
Conformance
Standard Title Standard Name Section No. and title (exclusion, Description Justification
(Y/N/NA)
SIS,
adaption)

medical devices - Part (subacute, subchronic and chronic

27. Recognitio 11: Tests for systemic systemic toxicity) Formatted: Normal, Indent: Left: 0.2", Space After: 0
n Number 2- toxicity pt, Line spacing: single, No bullets or numbering
118
Formatted: Font: 10 pt
1. Media The device is not
2. Alternative Thioglycolate Medium a
3. Soybean-Casein Digest Medium solution. It is
28. USP 35- 4. Media for Penicilins or Cephalosporins semi-rigid
membrane
NF30:2012 5. Suitability test which can be cut
filtration or
<71> Sterility tests 6. Sterility test YES TO ALL Option into
direct
Recognition 7. Growth Promotion Test of Aerobes, small pieces and
inoculation
No. 14-367 Anaeropes and Fungi suitable
8. Storage for the method
9. Diluting and Rinsing Fluids for of direct
membrane Filtration inoculation.
1. Apparatus and glassware
2. Preparation of the standard
endotoxin stock solution and
29. USP 35- standard solutions We choose to use
NF30:2012 3. Preparatory testing Yes to all EXCLUSION Gel-cloth
<85> Bacterial
4. Preparation of Sample Solutions except of techniques
Endotoxins test
Recognition 5. 5. Determination of maximum valid section 8 section 8 for LAL routine
No. 14-368 dilution (MVD) test for every lot.
6. Establishment of endotoxin limits
7. Gel-clot techniques
8. Photometer techniques