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Certificate
Shekel Scales certificate :
Healthweigh scales have the following international compliances and certifications: OIML (90/384/EEC); Class III (mandatory in Europe);
ISO 9000:2001 ; ISO 13485; RoHS, EN60601-1-2
EC TYPE APPROVAL
class III. Scales bearing this symbol correspond with precision class III of EC directive 90/384/EEC.
ISO 9001
9001:2000 Certification recognizes the manufacturer's quality system conforms to international standards for quality management and assurance
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ISO 13485 - ISO 13485:2003
The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.
QA system approval
Approval to make initial verification and meet the Requirements of BS EN 45501. As BS EN 45501 is equivalent to OIML R76, it is common that the test laboratory applies for the OIML certificate based upon the test results
EN60601-1-2
:2001+A1(06), section36 standard, harmonized under Medical Device Directive 93/42/EEC covering the Electromagnetic compatibility.
CISPR 1:2001+A2(06)group1 class B limits.
EN60601-1
:1990+A1:1993+A2:1995 covering the Safety compatibility.