GB/T 29252-2012 English PDF (GBT29252-2012)
GB/T 29252-2012 English PDF (GBT29252-2012)
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GB/T 29252-2012: Rule of the quality inspection of laboratory instruments and equipment
GB/T 29252-2012
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 19.040
N 61
Rule of the Quality Inspection of Laboratory Instruments
and Equipment
ISSUED ON: DECEMBER 31, 2012
IMPLEMENTED ON: JUNE 1, 2013
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Inspection Classification and Inspection Items ... 12
4.1 Inspection Classification ... 12
4.2 Exit-factory Inspection ... 13
4.3 Periodic Inspection ... 13
4.4 Type inspection ... 14
4.5 Inspection Items and Test Grouping ... 14
5 Inspection Conditions ... 16
5.1 Reference Conditions ... 16
5.2 Test Conditions ... 17
6 Nonconformity Classification ... 18
7 Exit-factory Inspection ... 19
7.1 100% Inspection ... 19
7.2 Sampling Inspection ... 19
7.3 Treatment after Passing Exit-factory Inspection ... 26
8 Periodic Inspection ... 26
8.1 Sampling and Grouping Rules ... 26
8.2 Inspection of Samples ... 27
8.3 Sampling Plan ... 27
8.4 Conformity Determination Method ... 30
8.5 Treatment after Periodic Inspection ... 30
9 Type Inspection ... 31
9.1 Sampling and Grouping Rules ... 31
9.2 Inspection of Samples ... 31
9.3 Sampling Plan ... 31
9.4 Conformity Determination Method ... 33
9.5 Treatment after Type Inspection ... 33
Rule of the Quality Inspection of Laboratory Instruments
and Equipment
1 Scope
This Standard specifies the terms and definitions, inspection classification and inspection items,
inspection conditions, nonconformity classification, exit-factory inspection, periodic inspection
and type inspection of the quality of laboratory instruments and equipment.
This Standard is applicable to the exit-factory inspection, periodic inspection and type
inspection of laboratory instruments and equipment.
2 Normative References
The following documents are indispensable to the application of this Document. In terms of
references with a specified date, only versions with a specified date are applicable to this
Document. In terms of references without a specified date, the latest version (including all the
modifications) is applicable to this Document.
GB/T 2828.1-2003 Sampling Procedures for Inspection by Attribute - Part 1: Sampling
Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot Inspection
GB/T 2829-2002 Sampling Procedures and Tables for Periodic Inspection by Attributes (apply
to inspection of process stability)
GB/T 13264 Sampling Procedures and Tables for Small Lot Inspection by Attributes for Percent
Nonconforming Items
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 Item
Item is a basic unit divided for the demand of carrying out sampling inspection.
[GB/T 2829-2002, Definition 3.1.1]
Example: a single product, a pair of products, a group of products, a component, or a part of a
certain length, a certain area, a certain volume and a certain weight.
3.2 Lot
Requirement refers to a demand or expectation that is explicitly expressed, usually implied, or
must be fulfilled.
[GB/T 19000-2008, Definition 3.1.2]
NOTE 1: “usually implied” refers to the routine or general practice of an organization, customer
and other interested parties where the demands or expectations under consideration are
self-evident.
NOTE 2: specific requirements may be expressed with modifying words, such as: product
requirements, quality management requirements and customer requirements.
NOTE 3: specified requirements are explicitly expressed requirements.
NOTE 4: requirements may be proposed by different interested parties.
3.9 Quality Characteristic
Quality characteristic refers to an inherent characteristic of a product, process or system related
to a requirement.
[GB/T 19000-2008, Definition 3.5.2]
NOTE 1: “inherent” refers to something inherent in some object, especially a permanent character.
NOTE 2: the characteristics (such as: the price of a product and the owner of a product) endowed
to a product, process or system are not its quality characteristics.
3.10 Conformity
Conformity refers to the satisfaction of a requirement.
[GB/T 19000-2008, Definition 3.6.1]
3.11 Nonconformity
Nonconformity refers to the failure to satisfy a requirement.
[GB/T 19000-2008, Definition 3.6.2]
NOTE: nonconformity is classified in accordance with the importance of quality indicated by
quality characteristic, or the severity of nonconformity of quality characteristic. Generally,
nonconformity is divided into nonconformity type A, nonconformity type B and
nonconformity type C.
3.12 Nonconformity Type A
Nonconformity type A means that an extremely important quality characteristic of an item fails
to satisfy a requirement, or the quality characteristic of an item extremely severely fails to
satisfy a requirement.
NOTE: GB/T 2829-2002, Definition 3.1.8 is modified.
3.13 Nonconformity Type B
Nonconformity type B means that an important quality characteristic of an item fails to satisfy
a requirement, or the quality characteristic of an item severely fails to satisfy a requirement.
NOTE: GB/T 2829-2002, Definition 3.1.9 is modified.
3.14 Nonconformity Type C
Nonconformity type C means that a general quality characteristic of an item fails to satisfy a
requirement, or the quality characteristic of an item slightly fails to satisfy a requirement.
NOTE: GB/T 2829-2002, Definition 3.1.10 is modified.
3.15 Nonconforming Item
Nonconforming item refers to an item with one or more nonconformities.
NOTE 1: in accordance with the severity of nonconformity, nonconforming item is usually divided
into nonconforming item type A, nonconforming item type B and nonconforming item
type C.
NOTE 2: GB/T 2828.1-2003, Definition 3.1.7 is modified.
3.16 Nonconforming Item Type A
Nonconforming item type A refers to an item with one or more nonconformities type A, and
probably nonconformity type B and (or) nonconformity type C.
[GB/T 2829-2002, Definition 3.1.12]
3.17 Nonconforming Item Type B
Nonconforming item type B refers to an item with one or more nonconformities type B, and
probably nonconformity type C, but no nonconformity type A.
[GB/T 2829-2002, Definition 3.1.13]
3.18 Nonconforming Item Type C
Nonconforming item type C refers to an item with one or more nonconformities type C, but no
nonconformity type A or nonconformity type B.
[GB/T 2829-2002, Definition 3.1.14]
3.19 Percent Nonconforming (in a sample)
Example: rework and degradation.
3.25 Rework
Rework refers to measures taken to bring nonconforming products into compliance.
[GB/T 19000-2008, Definition 3.6.7]
3.26 Inspection
Inspection refers to an activity of determining, inspecting, testing or measuring one or more
characteristics of a product, and comparing them with specified requirements in order to
determine whether the various characteristics of a product are conforming.
[GB/T 2828.1-2003, Definition 3.1.1]
3.27 Test
Test refers to the determination of one or more characteristics in accordance with a procedure.
[GB/T 19000-2008, Definition 3.8.3]
3.28 Acceptance Inspection
Exit-factory inspection
Acceptance inspection refers to an inspection carried out to determine whether the submitted
...
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GB/T 29252-2012: Rule of the quality inspection of laboratory instruments and equipment
GB/T 29252-2012
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 19.040
N 61
Rule of the Quality Inspection of Laboratory Instruments
and Equipment
ISSUED ON: DECEMBER 31, 2012
IMPLEMENTED ON: JUNE 1, 2013
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Inspection Classification and Inspection Items ... 12
4.1 Inspection Classification ... 12
4.2 Exit-factory Inspection ... 13
4.3 Periodic Inspection ... 13
4.4 Type inspection ... 14
4.5 Inspection Items and Test Grouping ... 14
5 Inspection Conditions ... 16
5.1 Reference Conditions ... 16
5.2 Test Conditions ... 17
6 Nonconformity Classification ... 18
7 Exit-factory Inspection ... 19
7.1 100% Inspection ... 19
7.2 Sampling Inspection ... 19
7.3 Treatment after Passing Exit-factory Inspection ... 26
8 Periodic Inspection ... 26
8.1 Sampling and Grouping Rules ... 26
8.2 Inspection of Samples ... 27
8.3 Sampling Plan ... 27
8.4 Conformity Determination Method ... 30
8.5 Treatment after Periodic Inspection ... 30
9 Type Inspection ... 31
9.1 Sampling and Grouping Rules ... 31
9.2 Inspection of Samples ... 31
9.3 Sampling Plan ... 31
9.4 Conformity Determination Method ... 33
9.5 Treatment after Type Inspection ... 33
Rule of the Quality Inspection of Laboratory Instruments
and Equipment
1 Scope
This Standard specifies the terms and definitions, inspection classification and inspection items,
inspection conditions, nonconformity classification, exit-factory inspection, periodic inspection
and type inspection of the quality of laboratory instruments and equipment.
This Standard is applicable to the exit-factory inspection, periodic inspection and type
inspection of laboratory instruments and equipment.
2 Normative References
The following documents are indispensable to the application of this Document. In terms of
references with a specified date, only versions with a specified date are applicable to this
Document. In terms of references without a specified date, the latest version (including all the
modifications) is applicable to this Document.
GB/T 2828.1-2003 Sampling Procedures for Inspection by Attribute - Part 1: Sampling
Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot Inspection
GB/T 2829-2002 Sampling Procedures and Tables for Periodic Inspection by Attributes (apply
to inspection of process stability)
GB/T 13264 Sampling Procedures and Tables for Small Lot Inspection by Attributes for Percent
Nonconforming Items
3 Terms and Definitions
The following terms and definitions are applicable to this document.
3.1 Item
Item is a basic unit divided for the demand of carrying out sampling inspection.
[GB/T 2829-2002, Definition 3.1.1]
Example: a single product, a pair of products, a group of products, a component, or a part of a
certain length, a certain area, a certain volume and a certain weight.
3.2 Lot
Requirement refers to a demand or expectation that is explicitly expressed, usually implied, or
must be fulfilled.
[GB/T 19000-2008, Definition 3.1.2]
NOTE 1: “usually implied” refers to the routine or general practice of an organization, customer
and other interested parties where the demands or expectations under consideration are
self-evident.
NOTE 2: specific requirements may be expressed with modifying words, such as: product
requirements, quality management requirements and customer requirements.
NOTE 3: specified requirements are explicitly expressed requirements.
NOTE 4: requirements may be proposed by different interested parties.
3.9 Quality Characteristic
Quality characteristic refers to an inherent characteristic of a product, process or system related
to a requirement.
[GB/T 19000-2008, Definition 3.5.2]
NOTE 1: “inherent” refers to something inherent in some object, especially a permanent character.
NOTE 2: the characteristics (such as: the price of a product and the owner of a product) endowed
to a product, process or system are not its quality characteristics.
3.10 Conformity
Conformity refers to the satisfaction of a requirement.
[GB/T 19000-2008, Definition 3.6.1]
3.11 Nonconformity
Nonconformity refers to the failure to satisfy a requirement.
[GB/T 19000-2008, Definition 3.6.2]
NOTE: nonconformity is classified in accordance with the importance of quality indicated by
quality characteristic, or the severity of nonconformity of quality characteristic. Generally,
nonconformity is divided into nonconformity type A, nonconformity type B and
nonconformity type C.
3.12 Nonconformity Type A
Nonconformity type A means that an extremely important quality characteristic of an item fails
to satisfy a requirement, or the quality characteristic of an item extremely severely fails to
satisfy a requirement.
NOTE: GB/T 2829-2002, Definition 3.1.8 is modified.
3.13 Nonconformity Type B
Nonconformity type B means that an important quality characteristic of an item fails to satisfy
a requirement, or the quality characteristic of an item severely fails to satisfy a requirement.
NOTE: GB/T 2829-2002, Definition 3.1.9 is modified.
3.14 Nonconformity Type C
Nonconformity type C means that a general quality characteristic of an item fails to satisfy a
requirement, or the quality characteristic of an item slightly fails to satisfy a requirement.
NOTE: GB/T 2829-2002, Definition 3.1.10 is modified.
3.15 Nonconforming Item
Nonconforming item refers to an item with one or more nonconformities.
NOTE 1: in accordance with the severity of nonconformity, nonconforming item is usually divided
into nonconforming item type A, nonconforming item type B and nonconforming item
type C.
NOTE 2: GB/T 2828.1-2003, Definition 3.1.7 is modified.
3.16 Nonconforming Item Type A
Nonconforming item type A refers to an item with one or more nonconformities type A, and
probably nonconformity type B and (or) nonconformity type C.
[GB/T 2829-2002, Definition 3.1.12]
3.17 Nonconforming Item Type B
Nonconforming item type B refers to an item with one or more nonconformities type B, and
probably nonconformity type C, but no nonconformity type A.
[GB/T 2829-2002, Definition 3.1.13]
3.18 Nonconforming Item Type C
Nonconforming item type C refers to an item with one or more nonconformities type C, but no
nonconformity type A or nonconformity type B.
[GB/T 2829-2002, Definition 3.1.14]
3.19 Percent Nonconforming (in a sample)
Example: rework and degradation.
3.25 Rework
Rework refers to measures taken to bring nonconforming products into compliance.
[GB/T 19000-2008, Definition 3.6.7]
3.26 Inspection
Inspection refers to an activity of determining, inspecting, testing or measuring one or more
characteristics of a product, and comparing them with specified requirements in order to
determine whether the various characteristics of a product are conforming.
[GB/T 2828.1-2003, Definition 3.1.1]
3.27 Test
Test refers to the determination of one or more characteristics in accordance with a procedure.
[GB/T 19000-2008, Definition 3.8.3]
3.28 Acceptance Inspection
Exit-factory inspection
Acceptance inspection refers to an inspection carried out to determine whether the submitted
...