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

Copyrights records by Association for the Advancement of Medical Instrumentation


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

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

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

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

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

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

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

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.
Names:
Association for the Advancement of Medical Instrumentation (183 documents)
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

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

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

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

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

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

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

Copyrights records by AAMI



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

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

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

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

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

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

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)

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

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

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

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

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

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

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