Annealing of medical metal materials for OEM manufacturing parts
Description
Heat Treatment is the controlled heating and cooling of metals to
alter their physical and mechanical properties without changing the
product shape.
Metal heating workpiece when it is exposed to the air, often occur
oxidation and decarburization (that is, the surface carbon content
lower) steel parts, the performance on the surface of the parts
after heat treatment have a bad effect.
1. To reduce brittleness and eliminate or reduce internal stress,
there exists great internal stress and brittleness after quenching
of steel parts. If the steel parts are not tempered timely,
deformation or even cracking will occur.
2. To obtain the required mechanical properties of workpiece, the
workpiece after quenching, high hardness and brittleness is big, in
order to meet the requirements of different performance of various
artifacts, can be tempered with appropriate to adjust the hardness,
decrease the brittleness, get the necessary toughness, plastic
3. Stabilized workpiece size
4. For some alloy steel which is hard to soften after annealing,
high temperature tempering is often adopted after quenching (or
normalizing) to make the carbide in the steel gather properly and
reduce the hardness for machining.
Quality Assurance
Jenitek is committed to supplying products and services that meet
the needs of customers, comply with statutory and regulatory
requirements, increase customer satisfaction and maintain the
effectiveness of the quality management systems through continuous
improvement in products, processes and services.
Jenitek's quality management system has been certified ISO
13485:2012 and ISO 9001:2008 in order to fulfill each of our
customers' specific requirements. FDA's QSR 21 CFR PART 820 and EU
MDD 93/42 EEC certifications are in process.
We have a thorough quality system including four levels of
documentation including manuals, procedures, work instructions and
records. According to system documentation and processes, our
quality activities such as production, inspection, product
development (NPI), process validation, supplier chain control, and
continuous improvement are controlled. This means we can deliver
precision, performance and safety products and services to our
customers around the world.
6 Sigma Quality Team The Jenitek quality team understands these
system standards are not only the foundation of quality management
but also paramount to the importance of our medical products,
customers and product development, production, and improvement
process. We have extensive experience with quality management and
use a range of methods and tools, including IQ/OQ/PQ, FMEA, PFMEA,
and Design of Experiments (DoE) to support in product development
and improvement processes.
Packing and Tracing
Products with validated sterile packing. Sealer and testing
equipment specifically configured to meet stringent packing
validation requirements.
Certificaton
•ISO 9001:2008 Certified
•ISO 13485:2012 Certified
•ISO 14001:2004 Certified
•OHSAS 18001 Certified
•FDA 21CFR 820 In-Process
•EU MDD 93/43 In-Process
•ISO 14971 2004 Compliance
