Standards used for the manufacture of Terragene´s products Numerical Reference Description Application ISO 13485 2016 Medical Devices Quality Management System Requirements for Regulatory Pusposes All.Medical Devices. Quality Management System. Requirements for Regulatory Pusposes. All Terragene®´s products Quality Management System. ISO 161421:2016 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices.
Standards used for the manufacture of Terragene´s products Numerical Reference Description Application ISO 13485:2016 Medical Devices Quality Management System Requirements for Regulatory Pusposes All Terragene®´s products - Quality Management System ISO 16142-1:2016 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices All Terragene®´s products ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements All Terragene®´s products Sterilization of health care products Biological indicators Part 1: General requirements All Terragene® Bionova® Biological Indicators, Bionova® Process Challenge Devices and Bionova® Culture Media Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes Terragene® Bionova® BT10, BT40, BT60, BT110, BTD40, BTD60, BTM40, BT110-IU Biological Indicators Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization processes Terragene® Bionova® BT20, BT50, BT60, BT21, BT22, BT23, BT24, BTD50, BTD60, BTM50, BT20S, BT24S, BT202, BT220, BT221, BT222, BT223, BT224 Biological Indicators, Bionova® PCD20-1, PCD20-2, PCD20C, PCD220-1, PCD220-2, PCD220-C, PCD222-1, PCD222-2, PCD222-C, PCD224-2, PCD224-C Process Challenge Devices Sterilization of health care products Biological indicators Part 4: Biological indicators for dry heat sterilization processes Terragene® Bionova® BT30, BT40, BT60, BTD40, BTD60, BTM40, BTM60 Biological Indicators, ISO 11138-1:2017 IRAM 37102-1:1999 ISO 11138-2:2017 IRAM 37102-2:1999 ISO 11138-3:2017 IRAM 37102-3:1999 ISO 11138-4:2017 ISO 11138-5:2017 Sterilization of health care products Biological indicators Part 5: Biological indicators for low - temperature steam and formaldehyde sterilization processes Terragene® Bionova® BT100 BT102 Biological Indicators and Numerical Reference Description Application - Guidance for Industry and FDA Staff Biological Indicator (BI) Premarket Notification [510(k)] Submissions Attachment II: Examples of Validation of Biological Indicator Incubation Time Terragene® Indicators Bionova® Biological ISO 11140-1:2014 IRAM 37101-1:1999 Sterilization of health care products Chemical indicators Part 1: General requirements Terragene® Chemink®, Indicators Chemdye®, Integron® Cintape®, Chemical ISO 11140-3:2007 Sterilization of health care products Chemical indicators Part 3: Class indicator systems for use in the Bowie and Dick-type steam penetration test Terragene Chemdye® BDA4 Chemical Indicator ISO 11140-4:2007 Sterilization of health care products Chemical indicators Part 4: Class indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration ISO 11140-5:2007 Sterilization of health care products Chemical indicators Part 5: Class indicators for Bowie and Dick-type air removal tests Terragene® Chemdye® BD125X/1, BDA4/1 BD8948X/1, KBD8948X/1 Chemical Indicators Guidance for Industry and FDA Staff Premarket Notification [510(k)] Submissions for Chemical Indicators Terragene® Chemdye®, Cintape® and Integron® Chemical Indicators EN 867-5:2001 Non-biological systems for use in sterilizers Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S Terragene® Chemdye® Helix system Chemical Indicators CDPCD2X15/P/M Helix Device ISO 18472:2018 Biological and chemical indicators Test equipment Terragene® Bionova® Biological Indicators, Chemdye®, Integron®, Cintape® and Chemink® Chemical Indicators ISO 15883-1:2006 Washer-disinfectors - Part 1: General requirements, terms and definitions and tests Terragene® Chemdye® PRO1 MICRO, KPRO2-E69 y KPRO2E-250 Cleaning Indicators – Hygiene Monitoring System ISO/TS 15883-5:2005 Washer-disinfectors - Part 5: Test soils and methods for demonstrating cleaning efficacy Terragene Chemdye® CDWA3, CDWA4, CDWAH, CDWE, Lumenia Line Terragene® Chemdye® BD125X10/2, BD8948X, Chemical Indicators BD125X/2, KBD8948X PCD with Numerical Reference Description Application HTM 01-01:2016 Health Technical Memorandum 01-01: Management and decontamination of surgical instruments (medical devices) used in acute care Part A: Management and provision Terragene® Chemdye® PRO1MICRO, KPRO2-E69 y KPRO2E-250 Cleaning Indicators – Hygiene Monitoring System HTM 01-05:2013 Health Technical Memorandum 01-05: Decontamination in primary care dental practices Terragene® Chemdye® PRO1MICRO, KPRO2-E69 y KPRO2E-250 Cleaning Indicators – Hygiene Monitoring System ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities Terragene® Bionova® Process Challenge Devices PCD20-1, PCD202, PCD20-C, PCD220-1, PCD220-2, PCD220-C, PCD222-1, PCD222-2, PCD222-C, PCD224-2, PCD224-C Terragene® Integron® Process Challenge Devices PCD26-1, PCD262, PCD26-C ... alternative to the Bowie and Dick-type test for detection of steam penetration ISO 11140-5:2007 Sterilization of health care products Chemical indicators Part 5: Class indicators for Bowie and... EN 867-5:2001 Non-biological systems for use in sterilizers Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type... of health care products Chemical indicators Part 1: General requirements Terragene® Chemink®, Indicators Chemdye®, Integron® Cintape®, Chemical ISO 11140-3:2007 Sterilization of health care products