Sterilization of health-care products 

 

ISO 11135:2017

Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

 

(suitable for heat/radiation sensitive materials)

 

 

 

DIN EN ISO 11137-1: 2015-11

 

 

 

Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013); German version EN ISO 11137-1:2015

 

DIN EN ISO 11137-2: 2015-11

 

 

Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015

DIN EN ISO 11137-3: 2015

 

Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO/DIS 11137-3:2015); German and English version prEN ISO 11137-3:2015

 

ISO 17665-1:2006-08

 

Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

 

ISO/TS 17665-2: 2009-01

 

Moist heat - Part 2: Guidance on the application of ISO 17665-1

ISO/TS 17665-3: 2013-04

 

Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization

 

 

ISO 11138-1

 

Biological indicators - Part 1: General requirements

ISO 11138-2

 

Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

 

ISO 11138-3

Biological indicators - Part 3: Biological indicators for moist heat sterilization processes

 

Source:

 

http://www.beuth.de/en

 

Temperature and temperature/humidity data-loggers

PyroButton-TH
Intrinsically Safe. Sensor and electronics are housed in a 305 ss food grade housing (i.e., FDA approved for use in food processing) of 17 mm diameter and 6 mm height. It is the smallest data-logger on the market.
Self-powered temperature/humidity data-logger

 

Temperature (-20 to +85°C), ±0.0625°C resolution, ±0.3°C accuracy

 

Humidity (3.4 – 97.3% RH), resolution ± 0.04% RH, ±2% RH accuracy

 

Calibrated at 5-temperature points relative to NIST reference and 5-humidity points. Each measurement is corrected relative to the calibration curve.

 

Data integrity protection for 21 CFR Part 11 requirement.

 

Source: http://www.pyrobutton.com/products/dataloggers.asp

 

 

Parametric release of sterile products

Parametric release effectively shortens sterilization-cycle time and reduces work-in-process. When process-capability has been shown to remain well within defined specification limits, sterilization-validation may allow parametric release of medical devices without 7 days waiting for growth of biological indicators.

 

Contact me to shorten your sterilization-cycle time.

Consulting   & Interim Management

Quality Management & Regulatory Affairs  Medical Devices & Combination products

 

Since 1994, effective Strategic & Operative experience in Quality Management & Regulatory Affairs for Medical Devices industry, within the fields of Ophthalmology, Neuro-stimulation, Vascular Intervention, Cardiology, Heart Surgery, Orthopedics, Dental Care, Modern Wound Care, Regional Anesthesia, Minimal Invasive Surgery, Navigated Robotic Surgery, CT & NMR digital Imaging (3D), and in vitro Diagnostics.

Technical Documentation (DHF, DMR, DHR) including Analysis & Evaluation of Product Function & Safety, Biocompatibility, Packaging, Labeling (UDI), Sterilization, Laboratory results, Software & Hardware.

Compliance to applicable Standards (ISO, IEC, EN, MIL).

Manufacturing Process Verification, Validation (IQ, OQ, PQ).

Product & Production-process Risk Management (Risk Analysis & Risk Control), including Additive Manufacturing. 

Clinical Evaluation, Organization of global multicenter Clinical Studies.

Audits of Production Processes & Suppliers.

Medical Device Reporting to Competent Authorities (e.g. BfArM, FDA).

Corrective And Preventive Action (CAPA) / Non-Conformity (NC) / corrective Project.

On site Support in Notified Body audits, and FDA inspections.

Effective management leading to a multitude of marketing approvals in the EU, Americas (FDA), & Asia, including Reimbursement schemes.

 

 

Dr. Hekmat CONSULTING

www.hekmat-consulting.de

 

USt-ID Nr.: DE295239280

 

Im Brühl 10/1, 72144 Dusslingen, Germany  (Stuttgart area)

Email: anusch.hekmat@gmail.com

Mobile: +49 170 8530715

Skype: anuschirawan.hekmat

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