Steam sterilization and sterility assurance using table-top sterilizers in office-based, ambulatory-care medical, surgical, and dental facilities part 2
The reuse of single-use medical devices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004632825 / 1997-09-04
Date of Publication:
November 30, 1996
Date of Creation:
1996
Title:
The reuse of single-use medical devices : guidelines for healthcare facilities.
Imprint:
Ottawa : CHA Press, c1996.
Description:
127 p.
Variant title:
The reuse of single-use medical devices : guidelines for healthcare facilities.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation
Authorship on Application:
Canadian Healthcare Association, employer for hire.
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Medical devices--symbols to be used with medical device labels, labeling and information to be supplied
Canadian Healthcare Association
example document: Medical devices--symbols to be used with medical device labels, labeling and information to be supplied
|
Canadian Healthcare Association
AAMI standards and recommended practices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004633951 / 1997-08-27
Date of Publication:
May 12, 1997
Date of Creation:
1997
Title:
AAMI standards and recommended practices : vol. 4 : biological evaluation of medical devices.
Edition:
1997 ed.
Basis of Claim:
New Matter: additions and revisions.
Imprint:
Arlington, VA : Association for the Advancement of Medical Instrumentation, c1997.
Description:
308 p.
Number of similar titles:
10
Variant title:
AAMI standards and recommended practices : vol. 4 : biological evaluation of medical devices.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Quality systems--medical devices--particular requirements for the application of ISO 9002
example document: Quality systems--medical devices--particular requirements for the application of ISO 9002
Guideline for establishing and administering medical instrumentation maintenance programs
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004636533 / 1997-08-29
Date of Publication:
January 1, 1993
Date of Creation:
1993
Title:
Guideline for establishing and administering medical instrumentation maintenance programs.
Description:
28 p.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products--biological indicators
example document: Sterilization of health care products--biological indicators
The quality system compendium
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004636596 / 1997-09-04
Date of Publication:
January 20, 1997
Date of Creation:
1997
Title:
The quality system compendium : GMP requirements & industry practice.
Imprint:
Arlington, VA : AAMI, c1997.
Description:
171 p.
Variant title:
The quality system compendium : GMP requirements & industry practice.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (employer for hire)
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization
example document: Sterilization
Design of clinical engineering quality assurance and risk management programs
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004639813 / 1997-09-15
Date of Publication:
January 1, 1990
Date of Creation:
1990
Title:
Design of clinical engineering quality assurance and risk management programs.
Series:
AAMI management information report ; no. 1-1990
Imprint:
Arlington, VA : AAMI, c1990.
Description:
38 p.
Other Title:
AAMI management information report ; no. 1-1990
Copyright Claimant:
Association for the Advancement of Medical Instrumentation
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products, radiation sterilization, substantiation of 25 kGy as a sterilization dose
example document: Sterilization of health care products, radiation sterilization, substantiation of 25 kGy as a sterilization dose
GMP requirements & industry practice
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004642835 / 1997-09-25
Date of Publication:
May 29, 1997
Date of Creation:
1997
Title:
GMP requirements & industry practice : instructor guide.
Edition:
Revision 5, 29May97.
Description:
72 p.
Number of similar titles:
1
Copyright Claimant:
Association for the Advancement of Medical Instrumentation
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Human factors design process for medical devices
example document: Human factors design process for medical devices
How to develop your quality system manual
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004642854 / 1997-08-22
Date of Publication:
February 11, 1997
Date of Creation:
1997
Title:
How to develop your quality system manual / by William Cotliar, Lawrence T. Bauer.
Edition:
5th ed.
Series:
Complying with FDA good manufacturing practice requirements
Imprint:
Arlington, VA : AAMI, c1996.
Description:
412 p.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (employer for hire)
Names:
William Cotliar
Lawrence T. Bauer
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization
Lawrence T. Bauer
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization
Steam sterilization and sterility assurance using table-top sterilizers in office-based, ambulatory-care medical, surgical, and dental facilities
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004945482 / 1999-04-05
Date of Publication:
January 9, 1998
Date of Creation:
1998
Title:
Steam sterilization and sterility assurance using table-top sterilizers in office-based, ambulatory-care medical, surgical, and dental facilities : ANSI/AAMI ST42.
Description:
35 p.
Variant title:
Steam sterilization and sterility assurance using table-top sterilizers in office-based, ambulatory-care medical, surgic
Copyright Claimant:
Association for the Advancement of Medical Instrumentation
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Quality systems--medical devices--particular requirements for the application of ISO 9002
example document: Quality systems--medical devices--particular requirements for the application of ISO 9002
AAMI standards and recommended practices
Type of Work:
Machine-readable work or computer program
Registration Number / Date:
TX0004945816 / 1999-03-30
Date of Publication:
January 30, 1998
Date of Creation:
1998
Title:
AAMI standards and recommended practices : version 97.2.
Edition:
Deluxe ed. on CD-ROM.
Basis of Claim:
New Matter: rev. compilation & additional text.
Previous Registration:
Prev. reg. 1997, TX 4-614-024.
Imprint:
Arlington, VA : Assn. for the Advancement of Medical Instrumentation, [1998]
Number of similar titles:
10
Copyright Claimant:
Association for the Advancement of Medical Instrumentation
Notes:
Database.
DOS 3.1 or higher, Windows 3.1 or higher, Macintosh system 7 or higher.
DOS 3.1 or higher, Windows 3.1 or higher, Macintosh system 7 or higher.
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Blood pressure measurement
example document: Blood pressure measurement
AAMI quality system standards handbook for medical devices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004955784 / 1999-03-30
Date of Publication:
November 17, 1997
Date of Creation:
1997
Title:
AAMI quality system standards handbook for medical devices.
Imprint:
Arlington, VA : Association for the Advancement of Medical Instrumentation, c1997.
Description:
71 p.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products--biological indicators
example document: Sterilization of health care products--biological indicators
Transport infant incubators
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004962054 / 1999-04-05
Date of Publication:
March 1, 1997
Date of Creation:
1997
Title:
Transport infant incubators : American national standard : ANSI/AAMI 1151--1996.
Description:
34 p.
Variant title:
Transport infant incubators : American national standard
Other Title:
ANSI/AAMI 1151--1996.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (employer for hire)
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products--chemical indicators--pt. 2, class 2 indicators for air removal test sheets and packs
example document: Sterilization of health care products--chemical indicators--pt. 2, class 2 indicators for air removal test sheets and packs
Table-top steam sterilizers
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004962055 / 1999-04-05
Date of Publication:
April 7, 1997
Date of Creation:
1997
Title:
Table-top steam sterilizers : American national standard : ANSI/AAMI ST55--1997.
Description:
24 p.
Variant title:
Table-top steam sterilizers : American national standard
Other Title:
ANSI/AAMI ST55--1997.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (employer for hire)
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of healthcare products
example document: Sterilization of healthcare products
Systems used to forecast remaining pacemaker battery service life
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0004962091 / 1999-04-05
Date of Publication:
January 30, 1998
Date of Creation:
1998
Title:
Systems used to forecast remaining pacemaker battery service life : AAMI TIR no. 21--1998.
Description:
53 p.
Variant title:
Systems used to forecast remaining pacemaker battery service life : AAMI TIR no. 21--1998.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products, radiation sterilization, selection of a sterilization dose for a single production batch
example document: Sterilization of health care products, radiation sterilization, selection of a sterilization dose for a single production batch
Recommended practice for a medical equipment management program
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005114676 / 1999-08-02
Date of Publication:
April 28, 1999
Date of Creation:
1999
Title:
Recommended practice for a medical equipment management program : ANSI/AAMI EQ56:1999.
Description:
23 p.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization
example document: Sterilization
ANSI/AAMI ST66:1999 sterilization of health care products--chemical indicators
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005135462 / 2000-02-15
Date of Publication:
October 1, 1999
Date of Creation:
1999
Title:
ANSI/AAMI ST66:1999 sterilization of health care products--chemical indicators : pt. 2, class 2 indicators for air removal test sheets and packs.
Imprint:
Arlington, VA : Association for the Advancement of Medical Instrumentation, c2000.
Description:
15 p.
Variant title:
ANSI/AAMI ST66:1999 sterilization of health care products--chemical indicators : pt. 2, class 2 indicators for air remov
Copyright Claimant:
Association for the Advancement of Medical Instrumentation
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products, biological indicators
example document: Sterilization of health care products, biological indicators
Signal averaging
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005219094 / 2000-07-03
Date of Publication:
May 15, 1999
Date of Creation:
1999
Title:
Signal averaging : approved 15 March 1999.
Series:
Technical information report ; AAMI TIR no. 23:1999
Description:
1 v.
Variant title:
Signal averaging : approved 15 March 1999.
Other Title:
Technical information report ; AAMI TIR no. 23:1999
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of medical devices--microbiological methods
AAMI (73 documents)
example document: Human factors design process for medical devices
example document: Sterilization of medical devices--microbiological methods
AAMI (73 documents)
example document: Human factors design process for medical devices
|
Processing of reusable surgical textiles for use in health care facilities
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005240590 / 2000-07-03
Date of Publication:
January 20, 2000
Date of Creation:
2000
Title:
Processing of reusable surgical textiles for use in health care facilities : ANSI/AAMI ST65:2000.
Description:
49 p.
Variant title:
Processing of reusable surgical textiles for use in health care facilities : ANSI/AAMI ST65:2000
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization
AAMI (73 documents)
example document: Nomenclature
example document: Sterilization
AAMI (73 documents)
example document: Nomenclature
Acquisition and use of physiologic waveform databases for testing of medical devices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005367054 / 2001-04-05
Date of Publication:
April 5, 2001
Date of Creation:
1999
Title:
Acquisition and use of physiologic waveform databases for testing of medical devices : AAMI TIR no. 24:1999.
Description:
44 p.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products
example document: Sterilization of health care products
AAMI standards and recommended practices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005368130 / 2001-04-03
Date of Publication:
June 1, 1998
Date of Creation:
1998
Title:
AAMI standards and recommended practices : vol. 3 : dialysis.
Basis of Claim:
New Matter: compilation & additions.
Previous Registration:
Prev. reg. 1997, TX 4-632-411.
Imprint:
Arlington, VA : AAMI, c1998.
Description:
466 p.
Number of similar titles:
10
Variant title:
AAMI standards and recommended practices : vol. 3 : dialysis.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Medical devices--risk management
AAMI (73 documents)
example document: Sterilization of health care products--radiation sterilization--substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
example document: Medical devices--risk management
AAMI (73 documents)
example document: Sterilization of health care products--radiation sterilization--substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
AAMI standards and recommended practices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005368131 / 2001-04-03
Date of Publication:
September 6, 2000
Date of Creation:
2000
Title:
AAMI standards and recommended practices : sterilization, pt. 1 : sterilization in health care facilities : vol. 1.1.
Edition:
2001 ed.
Basis of Claim:
New Matter: updating.
Previous Registration:
Prev. reg. 1997, TX 4-627-172.
Imprint:
Arlington, VA : AAMI, 2001.
Description:
1 v.
Number of similar titles:
10
Variant title:
AAMI standards and recommended practices : sterilization, pt. 1
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
AAMI (73 documents)
example document: Sterilization of medical devices--requirements for products labelled "sterile."
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products
example document: Sterilization of medical devices--requirements for products labelled "sterile."
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products
AAMI standards and recommended practices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005368132 / 2001-04-03
Date of Publication:
September 6, 2000
Date of Creation:
2000
Title:
AAMI standards and recommended practices : sterilization, pt. 2 : sterilization equipment : vol. 1.2.
Edition:
2001 ed.
Basis of Claim:
New Matter: updating.
Previous Registration:
Prev. reg. 1997, TX 4-632-507.
Imprint:
Arlington, VA : AAMI, 2001.
Description:
p. 653-892.
Number of similar titles:
10
Variant title:
AAMI standards and recommended practices : sterilization, pt. 2
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products, radiation sterilization, selection of a sterilization dose for a single production batch
AAMI (73 documents)
example document: Sterilization of medical devices
example document: Sterilization of health care products, radiation sterilization, selection of a sterilization dose for a single production batch
AAMI (73 documents)
example document: Sterilization of medical devices
Radiation sterilization
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005370787 / 2001-04-05
Date of Publication:
March 4, 1997
Date of Creation:
1997
Title:
Radiation sterilization : material qualification : AAMI TIR no. 17, 1997.
Edition:
1st ed.
Series:
Technical information report
Description:
1 v.
Number of similar titles:
1
Variant title:
Radiation sterilization : material qualification : AAMI TIR no. 17, 1997.
Other Title:
Technical information report
Copyright Claimant:
Association for the Advancement of Medical Instrumentation
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products--general requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
example document: Sterilization of health care products--general requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
Biological evaluation of medical devices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005371506 / 2001-04-05
Date of Publication:
December 4, 2000
Date of Creation:
2000
Title:
Biological evaluation of medical devices : pt. 8, Selection and qualification of reference materials for biological tests : American national standard, ANSI/AAMI/ISO 10993-2000.
Description:
1 v.
Number of similar titles:
8
Variant title:
Biological evaluation of medical devices : pt. 8
Other Title:
Selection and qualification of reference materials for biological tests
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products--general requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
AAMI (73 documents)
example document: Medical devices
example document: Sterilization of health care products--general requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
AAMI (73 documents)
example document: Medical devices
Active implantable medical devices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005377224 / 2001-04-06
Date of Publication:
February 22, 2001
Date of Creation:
2000
Title:
Active implantable medical devices : electromagnetic compatibility : EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators : ANSI/AAMI PC 69:2000.
Imprint:
Arlington, VA : Assn. for the Advancement of Medical Instrumentation, c2000.
Description:
23 p.
Variant title:
Active implantable medical devices : electromagnetic compatibility
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Breakthrough management
AAMI (73 documents)
example document: Sterilization of health care products--chemical indicators--pt. 2, class 2 indicators for air removal test sheets and packs
example document: Breakthrough management
AAMI (73 documents)
example document: Sterilization of health care products--chemical indicators--pt. 2, class 2 indicators for air removal test sheets and packs
Medical electrical equipment
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005392694 / 2001-11-07
Date of Publication:
November 1, 2000
Date of Creation:
2000
Title:
Medical electrical equipment : pt. 2, Particular requirements for the safety of infant radiant warmers : ANSI/AAMI/IEC 60601-2-21 & 60601-2-21 amendment 1:2000.
Copyright Note:
C.O. correspondence.
Description:
22 p.
Number of similar titles:
3
Variant title:
Medical electrical equipment : pt. 2
Other Title:
Particular requirements for the safety of infant radiant warmers
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Quality systems--medical devices--particular requirements for the application of ISO 9001
AAMI (73 documents)
example document: Sterilization of medical devices
example document: Quality systems--medical devices--particular requirements for the application of ISO 9001
AAMI (73 documents)
example document: Sterilization of medical devices
Process development and performance qualification for ethylene oxide sterilization--microbiological aspects
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005413952 / 2001-07-23
Date of Publication:
May 7, 2001
Date of Creation:
2001
Title:
Process development and performance qualification for ethylene oxide sterilization--microbiological aspects.
Series:
AAMI technical information report
Description:
18 p.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products, radiation sterilization, substantiation of 25 kGy as a sterilization dose
AAMI (73 documents)
example document: Sterilization of health care products--biological indicators
example document: Sterilization of health care products, radiation sterilization, substantiation of 25 kGy as a sterilization dose
AAMI (73 documents)
example document: Sterilization of health care products--biological indicators
Concentrates for hemodialysis
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005420865 / 2001-07-23
Date of Publication:
April 27, 2001
Date of Creation:
2001
Title:
Concentrates for hemodialysis : American national standard ANSI/AAMI RD61 : 2000.
Edition:
[1st ed.]
Description:
18 p.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Notes:
Partial revision of ANSI/AAMI RD5: 1992.
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization
AAMI (73 documents)
example document: Medical devices--quality management systems--requirements for regulatory purposes
example document: Sterilization
AAMI (73 documents)
example document: Medical devices--quality management systems--requirements for regulatory purposes
Ventricular assist and heart replacement systems
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005427966 / 2001-07-23
Date of Publication:
May 14, 2001
Date of Creation:
2001
Title:
Ventricular assist and heart replacement systems.
Application Title:
AAMI TIR 26.
Edition:
1st ed.
Series:
AAMI technical information report ; 26:2000
Description:
19 p.
Other Title:
AAMI technical information report ; 26:2000
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization
AAMI (73 documents)
example document: Medical devices--symbols to be used with medical device labels, labeling, and information to be supplied
example document: Sterilization
AAMI (73 documents)
example document: Medical devices--symbols to be used with medical device labels, labeling, and information to be supplied
Biological evaluation of medical devices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005565600 / 2001-04-02
Date of Publication:
July 16, 2000
Date of Creation:
2000
Title:
Biological evaluation of medical devices : vol. 4S2.
Edition:
2000 ed.
Basis of Claim:
New Matter: additions.
Copyright Note:
C.O. correspondence.
Description:
1 v.
Number of similar titles:
8
Variant title:
Biological evaluation of medical devices : vol. 4S2.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (AAMI)
Bacterial endotoxins--test methodologies, routine monitoring, and alternatives to batch testing
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005671818 / 2002-11-20
Date of Publication:
September 15, 2002
Date of Creation:
2002
Title:
Bacterial endotoxins--test methodologies, routine monitoring, and alternatives to batch testing : ANSI/AAMI ST72:2002.
Description:
24 p.
Variant title:
Bacterial endotoxins--test methodologies, routine monitoring, and alternatives to batch testing : ANSI/AAMI ST72:2002.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
example document: Sterilization of health care products--biological indicators
AAMI (73 documents)
example document: Medical devices--quality management systems--requirements for regulatory purposes
example document: Sterilization of health care products--biological indicators
AAMI (73 documents)
example document: Medical devices--quality management systems--requirements for regulatory purposes
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