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AAMI EC 53 pdf free download

AAMI EC 53 pdf free download.ECG trunk cables and patient leadwires.
3.4 FLEX RELIEF: The portion of the TRUNK CABLE or PATIENT LEADWIRE assembly at the junction of the connector to the assembly that prevents flexure of the assembly from damaging the assembly or the connector.
NOTE—FLEx RELIEF may be part of the strain relief. Strain relief is the part of a connector/cable that supports the connection and prevents forces that are applied to the cable from being transferred to the contacts and wires within the connector housing.
3.5 INSTRUMENT CONNECTOR: The connector on a TRUNK CABLE that mates to an INSTRUMENT CONNECTOR RECEPTACLE on an ECG DEVICE.
3.6 INSTRUMENT CONNECTOR RECEPTACLE: The connector on an ECG DEVICE that mates to an INSTRUMENT CONNECTOR.
3.7 MULThPAT1ENT USE: Products specifically not labeled for SINGLE USE or SINGLE-PATIENT USE.
3.8 PATiENT-END TERMINATiON: The connector on a PATIENT LEADWIRE that connects to an electrode on the PATIENT.
3.9 PATiENT LEADWIRE CONNECTOR: The connector on a PATIENT LEADWIRE that allows the leadwire to mate to a
CABLE YOKE (or directly to the ECG DEVICE having an integrated CABLE YOKE).
3.10 PATiENT LEADW1RE: A cable that ends with a PATIENT-END TERMINATION and a PATIENT LEADWIRE CONNECTOR.
3.11 SINGLE USE: Products specifically labeled as being for a single use on a single PATIENT.
3.12 SINGLE-PATiENT USE: Products specifically labeled as being for longer term use on a single PATIENT only.
3.13 TRUNK CABLE: The portion of the CABLE ASSEMBLY within which all wires are bundled together into one jacket or are in some way bound permanently together. Typically, this has a CABLE YOKE at one end with connectors for PATIENT LEADWIRES, and an INSTRUMENT CONNECTOR at the other end for connecting to the ECG DEVICE.
Test circuits
Unless otherwise specified, use resistors with a maximum ± 5% tolerance for frequencies up to 1 megahertz (MHz), non-polarized capacitors of suitable rating. with a maximum tolerance of ± 10% and inductors with a maximum tolerance of ± 5%.
Test signals
Unless otherwise specified, input test signals shall be accurate to ± 1% (d.c. voltages) or ± 2 % (a.c. voltages).
5 Requirements
5.1 aLabeling requirements
5.1.1 Package labeling
Each unit package supplied to the clinical OPERATOR shall have the following as part of a package insert or label:
This cable (or leadwire or set of leadwires] meets the requirements of the standard, ECG TRUNK CA&ES and
PATiENT LEADWIRES (ANSI/AAMI EC53). This cable (or leadwire or set of leadwires] is intended for SINGLE [or
SINGLE-PATIENT or MULTI-PATIENT] USE.
For TRUNK CABLES and PATIENT LEADWIRES that are not DEFIBRILLATION-PROOF, each unit package supplied to the clinical OPERATOR shall have the following as part of a package insert or label:
This cable [or leadwire or set of leadwiresj is not defibrillator-proof and should not be used in areas where a PATIENT might be defibrillated.
5.1.2 CABLE YOKE labeling
The CABLE YOKE shall have each PATIENT LEADWIRE position permanently marked (e.g., molded or engraved) with the appropriate electrode designation and color code per ANSI/AAMI/IEC 60601-2-27 or ANSIIAAMIIIEC 60601-247 Labeling of connection polarity is not requtred, but Is customary for products such as ambulatory ECG recorders.
5.1.3 PATIENT LEADWIRE termination labeling
If the entire wire is not appropriately color-coded, the terminations on both ends of the PATIENT LEADWIRE shall be color-coded per ANSI/AAMI/IEC 60601-2-27or ANSI!AAMI/IEC 60601-2-47. If the PATIENT LEADWIRE CONNECTOR is not separable from the CABLE YOKE, then only the PATIENT-END TERMINATION shall be color-coded.
The PATIENT-END TERMINATION should include nomenclature that reinforces the color designation (i.e., R, L).AAMI EC 53 pdf download.

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