Industrial metrology for medical products and devices: strategies, automation, FDA and MDR conformity
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Buch |
| Sprache: | English German |
| Veröffentlicht: |
Ellwangen
Opferkuch GmbH
2019
|
| Schriftenreihe: | A publication of ZEISS Metrology Academy
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis Inhaltsverzeichnis |
| Beschreibung: | 129 Seiten Illustrationen, Diagramme 24 cm, 416 g |
| ISBN: | 9783945380239 3945380235 |
Internformat
MARC
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| 240 | 1 | 0 | |a Industrielle Messtechnik für Medizinprodukte und -geräte |
| 245 | 1 | 0 | |a Industrial metrology for medical products and devices |b strategies, automation, FDA and MDR conformity |c summarized by Robert Roithmeier, Michael Wieler, Oberkochen |
| 264 | 1 | |a Ellwangen |b Opferkuch GmbH |c 2019 | |
| 300 | |a 129 Seiten |b Illustrationen, Diagramme |c 24 cm, 416 g | ||
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| 653 | |a MDR-Konform | ||
| 653 | |a Prüftechnik | ||
| 653 | |a mdr conformity | ||
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| 653 | |a fda conformity | ||
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| 653 | |a Messtechnik | ||
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Datensatz im Suchindex
| _version_ | 1804182575425519616 |
|---|---|
| adam_text | TABLE
OF
CONTENTS
1
INTRODUCTION
........................................................9
1.1
COORDINATE
METROLOGY
........................................
12
1.2
SURFACE
METROLOGY
..............................................16
2
WORKPIECES,
MEASURING
JOBS,
CHALLENGES
.......19
2.1
PRECISE
COMPONENTS
WITH
THE
HIGHEST
REQUIREMENTS
ON
FORM
AND
LOCATION
...............
20
2.2
FLEXIBLE
AND
THIN-WALLED
COMPONENTS
WITH
HIGH
DIMENSIONAL
REQUIREMENTS
.......................
22
2.3
MEASURING
PLASTIC
PARTS
COMPLETELY
BY
MEANS
OF
COMPUTER
TOMOGRAPHY
................................
25
2.3.1
COMPUTER
TOMOGRAPHY
IN
QUALITY
CONTROL
..
26
2.3.2
QUALITY
INSPECTION
IN
METROLOGY
...................
29
2.4
MEASURING
SMALL
FEATURES
SAFELY
AND
OPTICALLY
36
2.5
FORM
TOLERANCES,
SURFACE
PARAMETERS
AND
CONTOURS
.............................................................
38
2.6
OPTICAL
CAPTURE
OF
PLANES
AND
FREE
FORM
SURFACES
..............................................................
40
2.7
PRECISE
OPTICAL
MEASUREMENT
WITH
CONFOCAL
MICROSCOPES
IN
DENTAL
MEDICINE
.....................
44
2.8
TECHNICAL
CLEANLINESS
IN
THE
INDUSTRIAL
SECTOR
46
3
AUTOMATED
100%
CHECK
..................................
49
3.1
MINIMIZING
MANUFACTURING
AND
PROCESS
INFLUENCES
...........................................................
52
3.2
AUTOMATED
LOADING
...........................................
55
3.3
OPERATOR
CONCEPTS
...........................................
59
4
REGULATORY
REQUIREMENTS
ON
MEASURING
MACHINES
...........................................................
63
4.1
INCORPORATION
OF
MEASUREMENT
UNCERTAINTY..
65
4.2
MPE
VALUES
........................................................
66
4.3
MEASURING
SYSTEM
ANALYSIS:
CAPABILITY
AND
GR&R
TEST
..........................................................
73
4.3.1
CAPABILITY
INSPECTION
(TYPE
1
STUDY)
..............
74
4.3.2
GR&R
TEST:
REPEATABILITY
AND
REPRODUCIBILITY
(TYPE
2
AND
3
STUDY)
......................................
77
4.4
MACHINE
MONITORING
........................................
82
4.5
QUALIFICATION
OF
METROLOGISTS
...........................
83
5
REGULATORY
REQUIREMENTS
ON
MEASURING
PROCESSES
...........................................................
87
5.1
VALIDATION
OF
COMPUTER
SYSTEMS
....................
91
5.1.1
V
MODEL
OF
SOFTWARE
VALIDATION
...................
94
5.1.2
SOFTWARE
CATEGORIES
....................................
95
5.2
AUTOMATIC
ELECTRONIC
BACKUP
OF
MEASURING
RESULTS
ACCORDING
TO
21
CFR
PART
11
..............
98
5.2.1
STRUCTURE
MICROSCOPY
WORKFLOWS
GXP-
SECURELY
............................................
100
5.3
VALIDATION
OF
A
COORDINATE
MEASURING
MACHINE
IN
THE
MEDICAL
TECHNOLOGY
AREA
....................
101
5.4
MES
IN
THE
MEDICAL
TECHNOLOGY
ENVIRONMENT
105
A
21
CFR
PARTI
1
CHECKLIST
(EXTRACT)
..................
108
B
IMPORTANT
TERMS
USED
IN
METROLOGY
..............112
C
BIBLIOGRAPHY
....................................................
118
D
ILLUSTRATIONS
AND
TABLES
...................................
125
E
BOOKS
OF
THE
ZEISS
METROLOGY
ACADEMY
....
128
|
| adam_txt |
TABLE
OF
CONTENTS
1
INTRODUCTION
.9
1.1
COORDINATE
METROLOGY
.
12
1.2
SURFACE
METROLOGY
.16
2
WORKPIECES,
MEASURING
JOBS,
CHALLENGES
.19
2.1
PRECISE
COMPONENTS
WITH
THE
HIGHEST
REQUIREMENTS
ON
FORM
AND
LOCATION
.
20
2.2
FLEXIBLE
AND
THIN-WALLED
COMPONENTS
WITH
HIGH
DIMENSIONAL
REQUIREMENTS
.
22
2.3
MEASURING
PLASTIC
PARTS
COMPLETELY
BY
MEANS
OF
COMPUTER
TOMOGRAPHY
.
25
2.3.1
COMPUTER
TOMOGRAPHY
IN
QUALITY
CONTROL
.
26
2.3.2
QUALITY
INSPECTION
IN
METROLOGY
.
29
2.4
MEASURING
SMALL
FEATURES
SAFELY
AND
OPTICALLY
36
2.5
FORM
TOLERANCES,
SURFACE
PARAMETERS
AND
CONTOURS
.
38
2.6
OPTICAL
CAPTURE
OF
PLANES
AND
FREE
FORM
SURFACES
.
40
2.7
PRECISE
OPTICAL
MEASUREMENT
WITH
CONFOCAL
MICROSCOPES
IN
DENTAL
MEDICINE
.
44
2.8
TECHNICAL
CLEANLINESS
IN
THE
INDUSTRIAL
SECTOR
46
3
AUTOMATED
100%
CHECK
.
49
3.1
MINIMIZING
MANUFACTURING
AND
PROCESS
INFLUENCES
.
52
3.2
AUTOMATED
LOADING
.
55
3.3
OPERATOR
CONCEPTS
.
59
4
REGULATORY
REQUIREMENTS
ON
MEASURING
MACHINES
.
63
4.1
INCORPORATION
OF
MEASUREMENT
UNCERTAINTY.
65
4.2
MPE
VALUES
.
66
4.3
MEASURING
SYSTEM
ANALYSIS:
CAPABILITY
AND
GR&R
TEST
.
73
4.3.1
CAPABILITY
INSPECTION
(TYPE
1
STUDY)
.
74
4.3.2
GR&R
TEST:
REPEATABILITY
AND
REPRODUCIBILITY
(TYPE
2
AND
3
STUDY)
.
77
4.4
MACHINE
MONITORING
.
82
4.5
QUALIFICATION
OF
METROLOGISTS
.
83
5
REGULATORY
REQUIREMENTS
ON
MEASURING
PROCESSES
.
87
5.1
VALIDATION
OF
COMPUTER
SYSTEMS
.
91
5.1.1
V
MODEL
OF
SOFTWARE
VALIDATION
.
94
5.1.2
SOFTWARE
CATEGORIES
.
95
5.2
AUTOMATIC
ELECTRONIC
BACKUP
OF
MEASURING
RESULTS
ACCORDING
TO
21
CFR
PART
11
.
98
5.2.1
STRUCTURE
MICROSCOPY
WORKFLOWS
GXP-
SECURELY
.
100
5.3
VALIDATION
OF
A
COORDINATE
MEASURING
MACHINE
IN
THE
MEDICAL
TECHNOLOGY
AREA
.
101
5.4
MES
IN
THE
MEDICAL
TECHNOLOGY
ENVIRONMENT
105
A
21
CFR
PARTI
1
CHECKLIST
(EXTRACT)
.
108
B
IMPORTANT
TERMS
USED
IN
METROLOGY
.112
C
BIBLIOGRAPHY
.
118
D
ILLUSTRATIONS
AND
TABLES
.
125
E
BOOKS
OF
THE
ZEISS
METROLOGY
ACADEMY
.
128 |
| any_adam_object | 1 |
| any_adam_object_boolean | 1 |
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| author_facet | Roithmeier, Robert 1970- Wieler, Michael |
| author_role | aut aut |
| author_sort | Roithmeier, Robert 1970- |
| author_variant | r r rr m w mw |
| building | Verbundindex |
| bvnumber | BV047351541 |
| classification_rvk | ZQ 3950 |
| ctrlnum | (OCoLC)1233037266 (DE-599)DNB1221628364 |
| dewey-full | 681.7610287 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 681 - Precision instruments and other devices |
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| dewey-search | 681.7610287 |
| dewey-sort | 3681.7610287 |
| dewey-tens | 680 - Manufacture of products for specific uses |
| discipline | Handwerk und Gewerbe / Verschiedene Technologien Mess-/Steuerungs-/Regelungs-/Automatisierungstechnik / Mechatronik |
| discipline_str_mv | Handwerk und Gewerbe / Verschiedene Technologien Mess-/Steuerungs-/Regelungs-/Automatisierungstechnik / Mechatronik |
| format | Book |
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| id | DE-604.BV047351541 |
| illustrated | Illustrated |
| index_date | 2024-07-03T17:38:05Z |
| indexdate | 2024-07-10T09:09:44Z |
| institution | BVB |
| institution_GND | (DE-588)106429068X |
| isbn | 9783945380239 3945380235 |
| language | English German |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-032753724 |
| oclc_num | 1233037266 |
| open_access_boolean | |
| owner | DE-83 |
| owner_facet | DE-83 |
| physical | 129 Seiten Illustrationen, Diagramme 24 cm, 416 g |
| publishDate | 2019 |
| publishDateSearch | 2019 |
| publishDateSort | 2019 |
| publisher | Opferkuch GmbH |
| record_format | marc |
| series2 | A publication of ZEISS Metrology Academy |
| spelling | Roithmeier, Robert 1970- Verfasser (DE-588)12461244X aut Industrielle Messtechnik für Medizinprodukte und -geräte Industrial metrology for medical products and devices strategies, automation, FDA and MDR conformity summarized by Robert Roithmeier, Michael Wieler, Oberkochen Ellwangen Opferkuch GmbH 2019 129 Seiten Illustrationen, Diagramme 24 cm, 416 g txt rdacontent n rdamedia nc rdacarrier A publication of ZEISS Metrology Academy Carl Zeiss Jena GmbH (DE-588)2123709-8 gnd rswk-swf Betriebsmesstechnik (DE-588)4145052-8 gnd rswk-swf Medizinisches Gerät (DE-588)4038281-3 gnd rswk-swf MDR-Konform Prüftechnik mdr conformity Automatisierung fda conformity Prüfprozess Messtechnik Koordinatenmesstechnik Implantate Carl Zeiss Jena GmbH (DE-588)2123709-8 b Betriebsmesstechnik (DE-588)4145052-8 s Medizinisches Gerät (DE-588)4038281-3 s DE-604 Wieler, Michael Verfasser (DE-588)1224492218 aut Druckerei Opferkuch GmbH (Firma) (DE-588)106429068X pbl B:DE-101 application/pdf https://d-nb.info/1221628364/04 Inhaltsverzeichnis DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=032753724&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p dnb 20210120 DE-101 https://d-nb.info/provenance/plan#dnb 2\p dnb 20210120 DE-101 https://d-nb.info/provenance/plan#dnb |
| spellingShingle | Roithmeier, Robert 1970- Wieler, Michael Industrial metrology for medical products and devices strategies, automation, FDA and MDR conformity Carl Zeiss Jena GmbH (DE-588)2123709-8 gnd Betriebsmesstechnik (DE-588)4145052-8 gnd Medizinisches Gerät (DE-588)4038281-3 gnd |
| subject_GND | (DE-588)2123709-8 (DE-588)4145052-8 (DE-588)4038281-3 |
| title | Industrial metrology for medical products and devices strategies, automation, FDA and MDR conformity |
| title_alt | Industrielle Messtechnik für Medizinprodukte und -geräte |
| title_auth | Industrial metrology for medical products and devices strategies, automation, FDA and MDR conformity |
| title_exact_search | Industrial metrology for medical products and devices strategies, automation, FDA and MDR conformity |
| title_exact_search_txtP | Industrial metrology for medical products and devices strategies, automation, FDA and MDR conformity |
| title_full | Industrial metrology for medical products and devices strategies, automation, FDA and MDR conformity summarized by Robert Roithmeier, Michael Wieler, Oberkochen |
| title_fullStr | Industrial metrology for medical products and devices strategies, automation, FDA and MDR conformity summarized by Robert Roithmeier, Michael Wieler, Oberkochen |
| title_full_unstemmed | Industrial metrology for medical products and devices strategies, automation, FDA and MDR conformity summarized by Robert Roithmeier, Michael Wieler, Oberkochen |
| title_short | Industrial metrology for medical products and devices |
| title_sort | industrial metrology for medical products and devices strategies automation fda and mdr conformity |
| title_sub | strategies, automation, FDA and MDR conformity |
| topic | Carl Zeiss Jena GmbH (DE-588)2123709-8 gnd Betriebsmesstechnik (DE-588)4145052-8 gnd Medizinisches Gerät (DE-588)4038281-3 gnd |
| topic_facet | Carl Zeiss Jena GmbH Betriebsmesstechnik Medizinisches Gerät |
| url | https://d-nb.info/1221628364/04 http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=032753724&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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Inhaltsverzeichnis