IEC 60601-1-11 Medical Package Testing

IEC 60601-1-11 Medical Device Package Testing

This international standard applies to the basic safety of medical electrical equipment in the home healthcare environment. As an ISTA and ISO 17025 certified lab, we realize the importance of IEC 60601 testing. Meeting the home health care requirements can be difficult. We understand the challenges and guide companies through the process.

Keystone Package Testing partners with customers to achieve package compliance. When packages do not meet the requirements, we assist with finding solutions. We are in constant communication throughout the test process. We provide comprehensive reports shortly after the completion of the integrity compliance testing.

Request a quote and find out first hand about our competitive pricing, timely process, and outstanding reputation. Contact us to receive more information on IEC medical package testing.

Summary of IEC 60601-1-11 Home Health Care Package Testing

Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

Medical practice increasingly uses medical electrical equipment and medical electrical systems for monitoring, treatment, or diagnosis of patients in the home healthcare environment. The safety of medical electrical equipment in this uncontrolled environment with regard to the electrical installation and its related safety and protection means is a cause for concern.

The potential lack of training of the operator and possibly of those supervising the use of the medical electrical equipment or medical electrical system and their level of education need to be addressed in the development of the accompanying documents and in the relevant marking on the equipment itself so that this material can be understood.

IEC 60601-1-11 medical package test was developed with contributions from clinicians, engineers, and regulators.

The terminology, requirements, general recommendations, and guidance of EN 60601-1-11 are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards.

Why is IEC 60601-1-11 Medical Package Testing Important?

Overall, package integrity testing is a critical aspect of ensuring the safe and effective use of medical devices in home healthcare settings. It not only complies with regulatory requirements but also helps manufacturers uphold their commitment to patient safety and product quality.

Patient Safety

Medical devices intended for home use need to be packaged in a way that ensures they arrive at the user’s location in a safe and fully functional state. Package integrity testing helps identify potential issues like damaged packaging, which could compromise the sterility or functionality of the device, thus safeguarding patient safety.

Transportation and Handling

Medical devices often go through various stages of transportation and handling before reaching the end-user. Package integrity testing ensures that the packaging can withstand the stresses of transportation and handling without compromising the device’s integrity.

Compliance with Regulations

Adhering to the IEC 60601-1-11 standard is crucial for obtaining regulatory approvals for medical devices. Package integrity testing is often a requirement to demonstrate compliance with safety standards and regulations.

Product Performance and Reliability

Properly sealed packaging prevents any damage that might occur during storage or while being shipped. This helps maintain the performance and reliability of the medical equipment, ensuring it functions as intended when the patient uses it.

IEC 60601-1-11 Medical Device Package Testing Procedures

IEC 60601-1-11 and EN 60601-1-11 testing procedures give special guidance on how this should be addressed in the instructions for use.

Even the normal use of medical equipment in the home healthcare environment can be hazardous. Patients and their families, especially children, can be rough when handling equipment.

To address these conditions, test methods have been designed based on the medical devices use categories. The IEC 60601-1-11 test standard assigned categories to devices. These categories are based on whether the equipment is designed to be stationary or moved during normal use.

Within the two main categories are several sub-categories. These include mobile, portable, hand-held, and body-worn. The IEC 60601-11-1 package integrity testing standard includes the following chart that displays the qualitative assessment of home healthcare medical equipment subjected to shock and vibration:

Non-Transit-Operable Use


Transit-Operable Use



Expert IEC 60601-1 Medical Device Package Testing

Keystone Package Testing assists manufacturers with IEC 60601-1-11 and EN 60601-1-11 test compliance. Also, we have a full lab of test equipment which permits us to provide short lead times on scheduling. Our team strives to give our customers more time and energy on product development instead of testing.

Please contact us for more information on how Keystone Package Testing can assist you with identifying and fulfilling your IEC 60601-1-11 test lab needs. For more information on medical package testing, please follow the link: – Industries – Medical Devices

The standards listed below are most commonly used for medical devices to ensure safety and sterilization throughout the distribution process. If you are looking for a specific test that you do not see on this list, please search our site for that standard or request a quote.


Interested in the EMC/EMI, climatic, dynamic, shielding effectiveness, or IP Code testing of a product? Follow the corresponding links or for more information.