Safe handling and biological decontamination of reusable medical devices in health care facilties and in nonclinical settings
Medical electrical equipment
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005695507 / 2002-05-17
Date of Publication:
January 4, 2002
Date of Creation:
2002
Title:
Medical electrical equipment : pt. 1-2 : general requirements for safety : collateral standard : electromagnetic compatibility : requirements and tests : ANSI/AAMI/IEC 60601-1-2:2001.
Copyright Note:
C.O. correspondence.
Imprint:
Arlington, VA : Association for the Advancement of Medical Instrumentation, c2001.
Description:
77 p.
Variant title:
Medical electrical equipment : pt. 1-2 : general requirements for safety : collateral standard
Other Title:
American national standard
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Notes:
At head of ti.: American national standard.
Names:
Association for the Advancement of Medical Instrumentation
AAMI
|
|
AAMI
|
|
Product adoption and process equivalency for ethylene oxide sterilization
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005704059 / 2002-08-30
Date of Publication:
May 1, 2002
Date of Creation:
2002
Title:
Product adoption and process equivalency for ethylene oxide sterilization.
Copyright Note:
C.O. correspondence.
Series:
AAMI technical information report ; AAMI TIR28:2001
Description:
11 p.
Other Title:
AAMI technical information report ; AAMI TIR28:2001
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation
AAMI
AAMI
Biological evaluation of medical devices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005746860 / 2003-04-11
Date of Publication:
March 20, 2003
Date of Creation:
2002
Title:
Biological evaluation of medical devices : pt. 17, Establishment of allowable limits for leachable substances : ANSI/AAMI/ISO 10993-17:2002.
Edition:
1st ed.
Imprint:
Arlington, VA : Association for the Advancement of Medical Instrumentation, 2002.
Description:
21 p.
Variant title:
Biological evaluation of medical devices : pt. 17
Other Title:
Establishment of allowable limits for leachable substances
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation
AAMI
AAMI
Biological evaluation of medical devices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005746861 / 2003-04-11
Date of Publication:
March 20, 2003
Date of Creation:
2002
Title:
Biological evaluation of medical devices : pt. 4, Selection of tests for interactions with blood : ANSI/AAMI/ISO 10993-4:2002.
Edition:
2nd ed.
Basis of Claim:
New Matter: updating.
Previous Registration:
Prev. reg. 1997, TX 4-633-951.
Imprint:
Arlington, VA : Association for the Advancement of Medical Instrumentation, 2002.
Description:
29 p.
Variant title:
Biological evaluation of medical devices : pt. 4
Other Title:
Selection of tests for interactions with blood
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation
AAMI
AAMI
Resistometers used for characterizing the performance of biological and chemical indicators
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005748020 / 2003-04-15
Date of Publication:
April 1, 2003
Date of Creation:
2002
Title:
Resistometers used for characterizing the performance of biological and chemical indicators : ANSI/AAMI ST44:2002.
Application Title:
BIER/EO gas vessels, 3ed.
Description:
29 p.
Variant title:
Resistometers used for characterizing the performance of biological and chemical indicators : ANSI/AAMI ST44:2002.
Other Title:
BIER/EO gas vessels, 3ed.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Sterilization of medical devices--microbiological methods--pt. 3, Guidance on evaluation and interpretation of bioburden data
AAMI (51 documents)
example document: Sterilization of medical devices--microbiological methods--pt. 3, Guidance on evaluation and interpretation of bioburden data
example document: Sterilization of medical devices--microbiological methods--pt. 3, Guidance on evaluation and interpretation of bioburden data
AAMI (51 documents)
example document: Sterilization of medical devices--microbiological methods--pt. 3, Guidance on evaluation and interpretation of bioburden data
Packaging for terminally sterilized medical devices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005752814 / 2003-04-11
Date of Publication:
March 31, 2003
Date of Creation:
2002
Title:
Packaging for terminally sterilized medical devices.
Edition:
Rev., 2nd ed.
Basis of Claim:
New Matter: updated.
Previous Registration:
Prev. reg. 1997, TX 4-535-862.
Series:
ANSI/AAMI/ISO 11607-2000
Description:
19 p.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Notes:
American national standard.
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Sterilization of medical devices
AAMI
example document: Sterilization of medical devices
AAMI
AAMI standards on CD
Type of Work:
Machine-readable work or computer program
Registration Number / Date:
TX0005782143 / 2001-07-24
Date of Publication:
June 15, 2001
Date of Creation:
2001
Title:
AAMI standards on CD.
Basis of Claim:
New Matter: updating.
Previous Registration:
Prev. reg. 1999, TX 4-945-816.
Copyright Note:
C.O. correspondence.
Imprint:
Arlington, VA : AAMI, 2001.
Description:
CD-ROM.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Notes:
Database.
Names:
Association for the Advancement of Medical Instrumentation
AAMI
AAMI
Medical device software
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005784811 / 2003-06-17
Date of Publication:
September 27, 2001
Date of Creation:
2001
Title:
Medical device software : software life cycle processes : American national standard : ANSI/AAMI SW68:2001.
Imprint:
Arlington, VA : Association for the Advancement of Medical Instrumentation, c2001.
Description:
28 p.
Variant title:
Medical device software : software life cycle processes : American national standard : ANSI/AAMI SW68:2001
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Sterilization of health care products--chemical indicators--pt. 1, general requirements
AAMI (51 documents)
example document: Medical devices--quality management systems--guidance on the application of ISO 13485:2003
example document: Sterilization of health care products--chemical indicators--pt. 1, general requirements
AAMI (51 documents)
example document: Medical devices--quality management systems--guidance on the application of ISO 13485:2003
Reuse of hemodialyzers
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005855113 / 2003-11-10
Date of Publication:
April 22, 2003
Date of Creation:
2003
Title:
Reuse of hemodialyzers : ANSI/AAMI RD47 : 2002 & RD47:2002/A1 : 2003.
Edition:
[3rd ed. & amendment]
Description:
32 p.
Variant title:
Reuse of hemodialyzers : ANSI/AAMI RD47 : 2002 & RD47:2002/A1 : 2003
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Sterilization of health care products--biological indicators
AAMI
example document: Sterilization of health care products--biological indicators
AAMI
Biological evaluation of medical devices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005859898 / 2003-11-14
Date of Publication:
June 25, 2003
Date of Creation:
2003
Title:
Biological evaluation of medical devices : pt. 12 : sample preparation and reference materials : ANSI/AAMI/ISO 10993-12:2002.
Edition:
[2nd ed.]
Description:
12 p.
Variant title:
Biological evaluation of medical devices : pt. 12
Other Title:
ANSI/AAMI/ISO 10993-12:2002
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Notes:
Revision of ANSI/AAMI/ISO/CEN 10993-12:1996.
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Medical devices--quality management systems--requirements for regulatory purposes
AAMI (51 documents)
example document: Sterilization of health care products--vocabulary
example document: Medical devices--quality management systems--requirements for regulatory purposes
AAMI (51 documents)
example document: Sterilization of health care products--vocabulary
Clinical investigation of medical devices for human subjects
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005860198 / 2003-11-10
Date of Publication:
August 6, 2003
Date of Creation:
2003
Title:
Clinical investigation of medical devices for human subjects : pt. 1, general requirements : ANSI/AAMI/ISO 14155-1:2003.
Description:
18 p.
Variant title:
Clinical investigation of medical devices for human subjects : pt. 1, general requirements : ANSI/AAMI/ISO 14155-1:2003
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
AAMI (51 documents)
example document: Medical devices
example document: Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
AAMI (51 documents)
example document: Medical devices
Biological evaluation of medical devices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005871257 / 2003-04-11
Date of Publication:
March 20, 2003
Date of Creation:
2002
Title:
Biological evaluation of medical devices : pt. 10 : tests for irritation and delayed-type hypersensitivity : ANSI/AAMI BE78:2002 : American national standard.
Edition:
Rev., [2nd ed.]
Basis of Claim:
New Matter: revisions & additions.
Previous Registration:
Prev. reg. 1997, TX 4-633-951.
Description:
43 p.
Variant title:
Biological evaluation of medical devices : pt. 10
Other Title:
ANSI/AAMI BE78:2002
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Sterilization of health care products, radiation sterilization, selection of a sterilization dose for a single production batch
AAMI (51 documents)
example document: Sterilization of health care products--biological indicators
example document: Sterilization of health care products, radiation sterilization, selection of a sterilization dose for a single production batch
AAMI (51 documents)
example document: Sterilization of health care products--biological indicators
Process challenge devices/test packs for use in health care facilities
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005893738 / 2003-11-14
Date of Publication:
July 3, 2003
Date of Creation:
2003
Title:
Process challenge devices/test packs for use in health care facilities : AAMI TIR31:2003.
Description:
29 p.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation
AAMI
AAMI
Safe handling and biological decontamination of reusable medical devices in health care facilties and in nonclinical settings
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005895156 / 2003-11-03
Date of Publication:
July 22, 2003
Date of Creation:
2003
Title:
Safe handling and biological decontamination of reusable medical devices in health care facilties and in nonclinical settings : ANSI/AAMI ST35:2003.
Edition:
Revision of ANSI/AAMI ST35:1996.
Description:
68 p.
Variant title:
Safe handling and biological decontamination of reusable medical devices in health care facilties and in nonclinical
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation
AAMI
AAMI
Clinical investigation of medical devices for human subjects--part. 2, clinical investigation plans
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005926328 / 2003-11-14
Date of Publication:
August 15, 2003
Date of Creation:
2003
Title:
Clinical investigation of medical devices for human subjects--part. 2, clinical investigation plans.
Application Title:
ANSI/AAMI/ISO: 14155-2:2003.
Copyright Note:
C.O. correspondence.
Description:
7 p.
Variant title:
Clinical investigation of medical devices for human subjects--part. 2
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Medical devices--symbols to be used with medical device labels, labeling and information to be supplied
AAMI (51 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--symbols to be used with medical device labels, labeling and information to be supplied
AAMI (51 documents)
example document: Sterilization of health care products--radiation sterilization--substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
Leukocyte reduction filters
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005944176 / 2003-11-18
Date of Publication:
June 15, 2003
Date of Creation:
2003
Title:
Leukocyte reduction filters : ANSI/AAMI BF64:2002
Edition:
[1st ed.]
Copyright Note:
C.O. correspondence.
Description:
12 p.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Medical devices--risk management
AAMI (51 documents)
example document: Medical devices--quality management systems--guidance on the application of ISO 13485:2003
example document: Medical devices--risk management
AAMI (51 documents)
example document: Medical devices--quality management systems--guidance on the application of ISO 13485:2003
Manual, electronic or automated sphygmomanometers
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005946911 / 2003-11-13
Date of Publication:
May 5, 2003
Date of Creation:
2003
Title:
Manual, electronic or automated sphygmomanometers : ANSI/AAMI SP10:2002.
Edition:
3rd ed.
Copyright Note:
C.O. correspondence.
Imprint:
Arlington, VA : AAMI, c2003.
Description:
70 p.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation
AAMI)
AAMI)
Biological evaluation of medical devices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005954791 / 2004-04-01
Date of Publication:
January 7, 2004
Date of Creation:
2003
Title:
Biological evaluation of medical devices : pt. 3 : tests for genotoxicity, carcinogenicity and reproductive toxicity : ANSI/AAMI/ISO 10993-3:2003.
Previous Registration:
Preexisting material: earlier version.
Description:
14 p.
Variant title:
Biological evaluation of medical devices : pt. 3
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Sterilization dosimetry
AAMI
example document: Sterilization dosimetry
AAMI
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005963047 / 2004-03-08
Date of Publication:
January 12, 2004
Date of Creation:
2003
Title:
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities : ANSI/AAMI PB70:2003.
Description:
22 p.
Variant title:
Liquid barrier performance and classification of protective apparel and drapes
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation
AAMI
AAMI
AAMI standards on CD
Type of Work:
Machine-readable work or computer program
Registration Number / Date:
TX0005989067 / 2004-04-08
Date of Publication:
March 1, 2004
Date of Creation:
2004
Title:
AAMI standards on CD : version 2004.1.
Edition:
[2004 ed.]
Basis of Claim:
New Matter: updating & additions.
Previous Registration:
Prev. reg. 1999, TX 4-945-816.
Variant title:
AAMI standards on CD : version 2004.1
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Sterilization of health care products--biological indicators
AAMI
example document: Sterilization of health care products--biological indicators
AAMI
Medical electrical equipment
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0005997262 / 2004-04-01
Date of Publication:
March 1, 2004
Date of Creation:
2003
Title:
Medical electrical equipment : pt. 2-4, particular requirements for the safety of cardiac defibrillators (including automated external defibrillators) : ANSI/AAMI DF80:2003.
Edition:
Revision of ANSI/AAMI DF2:1996.
Copyright Note:
C.O. correspondence.
Description:
67 p.
Variant title:
Medical electrical equipment : pt. 2-4
Other Title:
ANSI/AAMI DF80:2003
ANSI/AAMI DF2:1996
ANSI/AAMI DF2:1996
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation
AAMI
AAMI
Medical device software risk management
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006151469 / 2005-03-21
Date of Publication:
February 19, 2005
Date of Creation:
2005
Title:
Medical device software risk management : AAMI TIR 32:2004.
Variant title:
Medical device software risk management : AAMI TIR 32:2004
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Notes:
Cataloged from appl. only.
Names:
Association for the Advancement of Medical Instrumentation
AAMI
AAMI
Dry heat (heated air) sterilizers ; ANSI/AAMI ST50
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006155392 / 2005-03-28
Date of Publication:
May 9, 2004
Date of Creation:
2004
Title:
Dry heat (heated air) sterilizers ; ANSI/AAMI ST50.
Variant title:
Dry heat (heated air) sterilizers
Other Title:
ANSI/AAMI ST50
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Notes:
Cataloged from appl. only.
Names:
Association for the Advancement of Medical Instrumentation
AAMI
AAMI
Dialysis book
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006157255 / 2005-03-23
Date of Publication:
October 29, 2004
Date of Creation:
2004
Title:
Dialysis book
Edition:
2005 ed.
Basis of Claim:
New Matter: additions & revisions.
Previous Registration:
Prev. reg. 2001, TX 5-368-130.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Notes:
Cataloged from appl. only.
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Medical devices--guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
AAMI (51 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--guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
AAMI (51 documents)
example document: Sterilization of health care products--radiation sterilization--substantiation of 25 kGy as a sterilization dose for small or infrequent production batches
Chemical indicators--guidance on the selection, use, and interpretation of results
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006164700 / 2005-03-28
Date of Publication:
February 22, 2005
Date of Creation:
2005
Title:
Chemical indicators--guidance on the selection, use, and interpretation of results : ANSI/AAMI/ISO 15882:2003.
Variant title:
Chemical indicators--guidance on the selection, use, and interpretation of results : ANSI/AAMI/ISO 15882:2003.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Notes:
Cataloged from appl. only.
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Nomenclature
AAMI
example document: Nomenclature
AAMI
Table-top steam sterizers
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006164701 / 2005-03-28
Date of Publication:
May 24, 2004
Date of Creation:
2004
Title:
Table-top steam sterizers : ANSI/AAMI ST55:2003.
Variant title:
Table-top steam sterizers : ANSI/AAMI ST55:2003.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Notes:
Cataloged from appl. only.
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Sterilization of health care products
AAMI
example document: Sterilization of health care products
AAMI
Industrial sterilization for medical devices
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006247506 / 2005-05-11
Date of Publication:
May 6, 2002
Date of Creation:
2002
Title:
Industrial sterilization for medical devices : course training materials.
Basis of Claim:
New Matter: new text & compilation.
Previous Registration:
Some text prev. pub.
Copyright Note:
C.O. correspondence.
Cataloged from appl. only.
Cataloged from appl. only.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Medical devices
AAMI (51 documents)
example document: Medical devices--quality management systems--guidance on the application of ISO 13485:2003
example document: Medical devices
AAMI (51 documents)
example document: Medical devices--quality management systems--guidance on the application of ISO 13485:2003
Design control requirements and industry practice
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006247913 / 2005-05-11
Date of Publication:
May 13, 1998
Date of Creation:
1998
Title:
Design control requirements and industry practice : course training materials.
Copyright Note:
C.O. correspondence.
Cataloged from appl. only.
Cataloged from appl. only.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Authorship on Application:
text & compilation in Power Point presentations: AAMI, employer for hire.
Names:
Association for the Advancement of Medical Instrumentation (77 documents)
example document: Sterilization of health care products
AAMI
example document: Sterilization of health care products
AAMI
Process validation requirements and industry practice
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006247914 / 2005-05-11
Date of Publication:
October 20, 1999
Date of Creation:
1999
Title:
Process validation requirements and industry practice : course training materials.
Basis of Claim:
New Matter: additional text & compilation in Power Point presentations.
Previous Registration:
Preexisting material: appendix.
Copyright Note:
C.O. correspondence.
Cataloged from appl. only.
Cataloged from appl. only.
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Authorship on Application:
text & compilation in Power Point presentations: AAMI, employer for hire.
Names:
Association for the Advancement of Medical Instrumentation (77 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
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
Medical electrical equipment
Type of Work:
Non-dramatic literary work
Registration Number / Date:
TX0006359720 / 2006-04-03
Date of Publication:
February 9, 2006
Date of Creation:
2005
Title:
Medical electrical equipment : pt. 1, General requirements for basic safety and essential performance : ANSI/AAMI ES60601-1:2005.
Copyright Note:
Cataloged from appl. only.
Other Title:
General requirements for basic safety and essential performance
ANSI/AAMI ES60601-1:2005
ANSI/AAMI ES60601-1:2005
Copyright Claimant:
Association for the Advancement of Medical Instrumentation (AAMI)
Names:
Association for the Advancement of Medical Instrumentation
AAMI
AAMI
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