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ASB_JA_CBAP Scope of Accreditation_v0_2014-04-15
Product Certification Scheme
:
ISO/IEC 17067, Conformity assessment - Fundamentals of product certification and guidelines
for product certification schemes, scheme type 3 most closely resembles the product
certification scheme operated by this organization. The surveillance part of this scheme
involves periodically taking samples of the product from the point of production and subjecting
them to determination activities to check that items produced subsequent to the initial
attestation fulfil the specified requirements. The surveillance includes periodic assessment of
the production process. This scheme does not provide any indication of the impact the
distribution channel plays on conformity. When serious nonconformities are found, the
opportunity may exist to resolve them before widespread market distribution occurs.
Scope of Accreditation
:
The scope of accreditation for the above-mentioned legal entity limits the use of the certification
mark shown, to products that meet standards classified by the following international
classification coding:
ICS No.
Title
Purpose
11.040.10
Aneasthetic, respiratory and reanimation equipment
Electrical Safety
11.040.20
Transfusion, infusion and injection equipment
Electrical Safety
11.040.30
Surgical instruments and materials
Electrical Safety
11.040.50
Radiographic equipment
Electrical Safety
11.040.55
Diagnostic equipment
Electrical Safety
11.040.60
Therapy equipment
Electrical Safety
11.060.20
Dental equipment
Electrical Safety
11.120
Pharmaceutics (child restrictive packaging)
Safety
11.140
Hospital equipment
Electrical Safety
13.030.40
Installations and equipment for waste disposal and treatment
Performance