CONFIDENTIAL

Double Loop Ureteral Stent

Section: 5
Technical Documentation

5. Applicable Standards and Common Specifications

Reference: TD-URO-DLU-STD-05 Issue: 02 Date: 04/2022 Page 1

 CONFIDENTIAL

Double Loop Ureteral Stent

Section: 5
Technical Documentation

Device Name: Amecath Double Loop Ureteral Stent (Stent / Stent Kits and Accessories)

List of standards applied and common specifications fully to guarantee conformity of the medical devices
with general safety and performance requirements.

Reference name
Reference

BS EN ISO 13485:2016+A11:2021 Medical devices. Quality management systems. Requirements for regulatory purposes

BS EN ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories

ISO 14001:2015 Environmental management systems. Requirements with guidance for use

IEC 62366-1:2015/Amd 1:2020 Application of usability engineering to medical devices — Amendment 1

IEC/TR 62366-2:2016 Guidance on the application of usability engineering to medical devices

Quality management. Customer satisfaction. Guidelines for complaints handling in

ISO 10002:2018
organizations

ISO 19011:2018 Guidelines for auditing management systems

ISO 15489-1:2016 Information and documentation. Records management. Concepts and principles

ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice

BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices

ISO/TR 24971:2020 Medical devices — Guidance on the application of ISO 14971

Biological evaluation of medical devices. Evaluation and testing within a risk management
ISO 10993-1:2018
process

BS EN ISO 10993 - 7 :2008 / Amd1

Biological evaluation of medical devices. Ethylene oxide sterilization residuals
:2019

Biological evaluation of medical devices. Chemical characterization of medical device

ISO 10993-18:2020
materials within a risk management process

Cleanrooms and associated controlled environments. Classification of air cleanliness by

ISO 14644-1:2015
particle concentration

Cleanrooms and associated controlled environments. Monitoring to provide evidence of

ISO 14644-2 :2015
cleanroom performance related to air cleanliness by particle concentration

ISO 14644-3:2019 Cleanrooms and associated controlled environments. Test methods

ISO 14644-4 :2001 Cleanrooms and associated controlled environments. Design, construction and start-up

Cleanrooms and associated controlled environments. Classification of air cleanliness by

ISO 14644-8 :2013
chemical concentration (ACC)

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 CONFIDENTIAL

Double Loop Ureteral Stent

Section: 5
Technical Documentation

Cleanrooms and associated controlled environments. Classification of surface cleanliness

ISO 14644-9:2012
by particle concentration

BS EN 17141:2020 Cleanrooms and associated controlled environments. Biocontamination control

ISO 10005:2018 Quality management. Guidelines for quality plans

Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and
BS EN 868-2:2017
test methods

Packaging for terminally sterilized medical devices. Requirements for materials, sterile
ISO 11607-1:2019
barrier systems and packaging systems

Packaging for terminally sterilized medical devices. Validation requirements for forming,
ISO 11607-2:2019
sealing and assembly processes

BS EN ISO 20417:2021 Medical devices — Information to be supplied by the manufacturer

Medical devices. Symbols to be used with medical device labels, labelling and information
ISO 15223-1:2021
to be supplied. General requirements

Medical devices. Symbols to be used with medical device labels, labelling, and information
BS ISO 15223-2:2010
to be supplied. Symbol development, selection and validation

BS EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical devices

Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test
BS EN 1422:2014
methods

Sterilization of health-care products — Ethylene oxide — Requirements for the

ISO 11135:2014/Amd 1:2018 development, validation and routine control of a sterilization process for medical devices
— Amendment 1: Revision of Annex E, Single batch release

Sterilization of medical devices. Requirements for medical devices to be designated

BS EN 556-1:2001
"STERILE". Requirements for terminally sterilized medical devices

Sterilization of health care products. General requirements for characterization of a

ISO 14937:2009 sterilizing agent and the development, validation and routine control of a sterilization
process for medical devices

ISO 11138-1:2017 Sterilization of health care products. Biological indicators. General requirements

Sterilization of health care products. Biological indicators. Guidance for the selection, use
BS EN ISO 11138-7:2019
and interpretation of results

Sterilization of health care products. Microbiological methods. Determination of a

ISO 11737-1:2018/Amd 1:2021
population of microorganisms on products

Sterilization of health care products. Microbiological methods. Tests of sterility performed

ISO 11737-2:2019
in the definition, validation and maintenance of a sterilization process

USP 42 USP 〈 85 〉 General chapter — BACTERIAL ENDOTOXINS TEST

USP 〈 161 〉 MEDICAL DEVICES—BACTERIAL ENDOTOXIN AND

USP 42
PYROGEN TESTS

USP 42 USP 〈 71 〉 STERILITY TESTS

Guidance on the selection and usage of acceptance sampling systems for inspection of
ISO/TR 8550-1:2007
discrete items in lots — Part 1: Acceptance sampling

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 CONFIDENTIAL

Double Loop Ureteral Stent

Section: 5
Technical Documentation

Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by

ISO 2859-1:1999/Amd 1:2011
acceptance quality limit (AQL) for lot-by-lot inspection — Amendment 1

Sampling procedures for inspection by attributes — Introduction to the ISO 2859 series of
ISO 28590:2017
standards for sampling for inspection by attributes

Sampling procedures for inspection by attributes. Sampling plans indexed by limiting

ISO 2859-2:2020
quality (LQ) for isolated lot inspection

Sampling procedures for inspection by variables. Specification for single sampling plans
ISO 3951-1:2013 indexed by acceptance quality limit (AQL) for lot-by-lot inspection for a single quality
characteristic and a single AQL

Sampling procedures for inspection by variables. General specification for single sampling
ISO 3951-2:2013 plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent
quality characteristics

ISO 8573-1:2010 Compressed air. Contaminants and purity classes

ISO 8573-3:1999 Compressed air. Test methods for measurement of humidity

ISO 8573-7:2003 Compressed air. Test method for viable microbiological contaminant content

ASTM F1980 - 21 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ASTM D4169 – 22 Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM D5276 – 19 Standard Test Method for Drop Test of Loaded Containers by Free Fall

ASTM D6344 - 04(2017) Standard Test Method for Concentrated Impacts to Transport Packages

ASTM D999 - 08(2015) Standard Test Methods for Vibration Testing of Shipping Containers

Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained

ASTM F1140 / F1140M - 13(2020)e1
Packages

Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye
ASTM F1929 – 15
Penetration

ASTM F88 / F88M - 21 Standard Test Method for Seal Strength of Flexible Barrier Materials

BS EN 13868:2002 Catheters. Test methods for kinking of single lumen catheters and medical tubing

BS EN ISO 14630:2012 Non-active surgical implants. General requirements

ASTM D412 - 16(2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers. Tension

Small-bore connectors for liquids and gases in healthcare applications. Common test
BS EN ISO 80369-20:2015
methods

ASTM E515 - 11(2018) Standard Practice for Leaks Using Bubble Emission Techniques

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