Our products are principally CE compliant. On request our products may be equipped to meet the following standards: AMS 2750 E (July 2012), CQI-9-HTSA and Title 21 CFR Part 11.
“CE stands for “Communautés Européennes“.
The mark, which is addressed to public authorities and not consumers, indicates conformity with the “essential safety requirements” set out in New Approach EU Directives. Manufacturers are responsible for testing and declaring conformity with the directives.”
AMS 2750 E (Jul. 2012)
“Scope: This specification covers pyrometric requirements for thermal processing equipment used for heat treatment. It covers temperature sensors, instrumentation, thermal processing equipment, system accuracy tests, and temperature uniformity surveys. These are necessary to ensure that parts or raw materials are heat treated in accordance with the applicable specification(s). “
SAE Aerospace: AMS 2750 E – Pyometry. Aerospace Material Specification (July 2012)
Further Information: http://standards.sae.org/ams2750e/
The work of preparing CQI 9: Special Process: Heat Treat System Assessment (HTSA), Third Edition, was carried out through the AIAG Heat Treat Work Group. These heat treat requirements are complementary to customer and product standards. The HTSA can be used to assess an organization’s ability to meet the requirements in this assessment, as well as customer, regulatory, and the organization’s own requirements. HTSA can also be used between an organization and its suppliers. It supports the automotive process approach as described in ISO/TS 16949.
The goal of the HTSA is the development of a heat treat management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. HTSA coupled with an internationally recognized quality management system and applicable customer-specific requirements, defines the fundamental requirements for heat treat management systems. The HTSA is intended to provide a common approach to a heat treat management system for automotive production and service part organizations.”
Automotive Industry Action Group: Heat Treat System Assessment. URL http://www.aiag.org/, Mai 19, 2018
Title 21 CFR Part 11
“Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries, with some specific exceptions, to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. “
Source: http://en.wikipedia.org/wiki/Title_21_CFR_Part_11, 12. Juni, 2012
Further information: http://www.fda.gov