IS 18529: Standard for Safe and Effective Intravascular Access Devices

This Indian Standard IS 18529 outlines the requirements for single-use, sterile intravascular introducers, dilators, and guidewires used with intravascular catheters. It ensures safety, performance, and reliability through detailed specifications, testing methods, and guidelines for manufacturers. The standard includes requirements and test methods to enhance guidewire functionality and improved size designations for compatibility and standardisation.

Scope of the Standard

The standard applies to:

• Introducer needles
• Introducer catheters
• Sheath introducers
• Guidewires
• Dilators These are supplied sterile and intended for single-use in conjunction with intravascular catheters?

General Requirements

1. Sterilisation: Devices must comply with ISO sterilisation standards
2. Biocompatibility: Materials must meet ISO 10993-1 to ensure safety.
3. Surface Quality: Devices should be free of visible defects or contaminants.
4. Corrosion Resistance: Metallic components must pass tests per Annex B.
5. Radiodetectability: Certain components must be radiodetectable if specified in the risk assessment.

Key Device-Specific Requirements

Introducer Needles

• Size Designation: Based on the outside diameter, inside diameter, and length.
• Needle Point: Must be sharp, free of burrs, and defects.
• Strength: Needle hub and tube union must withstand forces per Annex I.

Introducer Catheters

• Tip Design: Must ensure minimal trauma and fit closely with the needle.
• Peak Tensile Force: Junctions between catheter and hub must meet tensile strength criteria (Annex C).
• Warnings: Manufacturers must caution against re-inserting withdrawn needles.

Sheath Introducers

• Leak Resistance: Must pass liquid leakage tests under 300 kPa pressure.
• Haemostasis Valve: Should prevent leaks as per Annex E.
• Tensile Strength: Junctions must meet force standards per Annex C.

Guidewires

• Size Designation: Based on maximum diameter (rounded up to nearest 0.01 mm) and nominal length.
• Safety: Must include a safety wire unless core wire is attached to the tip.
• Fracture & Flexing Tests: Guidewires should resist damage or coating flaking (Annex F, G).

Dilators

• Size Designation: Includes maximum outside diameter, minimum internal diameter, and effective length.
• Hub Strength: Must comply with tensile force requirements.

Why do we need an Indian Standard for Medical Devices?

Standards like IS 18529 play a pivotal role in maintaining the safety, reliability, and effectiveness of medical devices like single-use, sterile intravascular introducers, dilators, and guidewires used with intravascular catheters. By adhering to these guidelines, manufacturers can ensure that their products meet global benchmarks, fostering trust among healthcare professionals and patients alike.

With advancements in medical technology, such standards are critical to ensuring that devices used in life-saving procedures are not only effective but also safe. Whether it’s an introducer needle, a guidewire, or a dilator, IS 18529 ensures that every component performs flawlessly, safeguarding lives.

???? 18529 ?????????? ?????????? ????????? ?? ??? ???????????

?? ?????? ???? ???? 18529 ??? ?????????? ???????? ?? ??? ??????? ??? ????? ?????????? ?????????? ??????????????, ?????????? ?? ?????????? ?? ????????? ???????? ?? ?? ??? ?? ???? ??????? ????????, ??????? ????????? ?? ???????????? ?? ??? ????????????? ?? ?????? ?? ???????, ???????? ?? ??????????? ????????? ???? ??? ?? ???? ??? ???????? ? ???????? ???? ???????? ?? ?????????? ??? ????? ???? ???????? ?? ?????? ?? ??? ????????? ?? ??????? ????????? ?? ?? ????

???? ???????

?? ???? ?????????? ?? ???? ???? ???

· ? ? ? ? ???????????? ???

· ? ? ? ? ???????????? ????????

· ? ? ? ? ??? ????????????

· ? ? ? ? ????????

· ? ? ? ? ??????????

?????? ?????????? ?????? ??? ??????? ?? ?? ?? ?? ?????? ?????????? ?????? ?? ??? ??? ????????? ????? ??? ???

??????? ?????????

· ??????????: ????????? ????? ?????????? ?????? (????? 17665, ????? 11135, ????? 11137) ?? ??????? ????

· ??? ??????: ??????? ??????? ????????? ???? ???? ????? 10993-1 ?? ?????? ????

· ??? ?? ?????: ????????? ????? ??? ?? ????? ???? ???

· ???????? ????????: ???? ????? ?? ????????-? ?? ?????? ??????? ??? ???

· ????????????????????: ????? ????????? ??? ????????? ???? ?? ??? ????? ?? ???????????????????? (??????-?????? ?????) ???

?????? ?? ??????? ?????????

??????????? ???

· ???? ??????: ????? ?????, ?????? ????? ?? ????? ?? ???? ???

· ??? ?????: ?? ???????, ???????? ?? ??? ???? ???

· ??????????: ??? ?? ?? ????? ?????? ?? ??????-? ?? ?????? ?? ????

?

??????????? ??????

· ???? ??????: ??????? ?????? ????????? ???? ????? ?? ??? ?? ??? ???? ??? ?? ??? ???

· ??????? ?????? ??: ?????? ?? ?? ?? ??? ???????? ?? ?????? ???????? ?????? (??????-?) ?? ?????? ???

· ??????????: ???????? ?? ?????? ?? ?????? ?? ???? ????? ??? ??????? ??????

??? ????????????

· ?????? ????????: 300 ????? ??? ?? ??? ??? ????? ??????? ??? ????

· ???????????? ?????: ??????-? ?? ?????? ????? ?? ?????

· ???? ????????: ?????? ??????-? ?? ?????? ?? ?????? ?? ?????? ???

????????

· ???? ??????: ?????? ????? (?????? 0.01 ???? ?? ???) ?? ????? ????? ?? ???? ???

· ????????: ??? ???? ??? ?? ????? ???? ?? ??????? ??? ????? ???

· ???? ?? ?????? ???????: ???????? ????? ?? ???? ???????? (?????? ?, ?) ????????? ???

??????????

· ???? ??????: ?????? ????? (?????? 0.01 ???? ?? ??????????) ?? ????? ????? ?? ???? ?? ???

· ??? ????????: ??? ?? ????????? ?? ??????? ???

?

???? 18529 ?? ????? ????? ???

???? 18529 ???? ???? ???????? ????????? ?? ???????, ??????????? ?? ??????????? ?? ???? ???? ??? ?????????? ???? ?? ????????????? ?? ???? ???? ?????????? ?? ????????? ?? ???? ??? ?? ???? ?????? ??????? ???????? ?? ???? ???? ??? ????? ????????? ???? ???????? ?? ??????? ??? ??????? ????? ???

???????? ???????????? ??? ?????? ?? ??? ??? ???? ?? ????????? ???? ?? ??? ?????????? ??? ?? ???? ????? ??????????? ??? ?????? ?? ???? ???? ????????? ? ???? ??????? ??? ????? ???????? ?? ???? ???? ?? ???????????? ??? ??, ???????? ??, ?? ?????????? ??, ???? 18529 ?? ????????? ???? ?? ?? ???????? ??? ???? ?? ??????? ???? ??? ??????? ????? ?? ??? ????