IEC Compliance - Fibra Inc.

IEC 60601 Safety Compliance

Understanding IEC 60601 Medical Safety Standards

The IEC 60601 standard establishes safety and performance requirements for medical electrical equipment, including specifications for physical durability, electrical safety, and cleaning procedures for body-worn devices used in healthcare environments.

This internationally recognized standard ensures that medical devices meet strict requirements for patient protection from electrical hazards, prevention of fire and mechanical risks, electromagnetic interference immunity, and reliable performance under both normal and fault conditions.

For wearable medical devices, IEC 60601 compliance demonstrates rigorous testing for safe patient contact, proper electrical isolation, waterproof integrity for cleaning and disinfection, and reliable wireless communication without interference. Our comprehensive compliance reflects our commitment to patient safety and regulatory excellence.

Physical Protection Standards

Medical devices must demonstrate adequate protection against moisture ingress and maintain functionality under mechanical stress conditions including impact exposure.

Our Implementation: Our fully overmolded electronics unit utilizes biocompatible materials, delivering enhanced moisture protection while exceeding impact resistance requirements.

Electrical Safety Requirements

The standard mandates strict limits on electrical current that can flow through patient contact points, with specific thresholds for leakage currents under both normal operation and fault conditions.

Our Implementation: Advanced electrical isolation architecture maintains all patient-contact currents well below regulatory thresholds, ensuring safe operation across all connection points and applied components during standard use scenarios.

Battery Safety Provisions

Safety measures must prevent battery-related hazards including overcharge conditions and accidental short circuits that could create dangerous situations for patients or operators.

Our Implementation: Integrated battery management circuitry employs controlled charging protocols to prevent overcharge scenarios, while our sealed battery compartment design eliminates short-circuit risks.

Cleaning and Disinfection Compatibility

Equipment design must accommodate required cleaning and disinfection procedures without compromising safety features or device performance over the product lifecycle.

Our Implementation: The detachable electronics architecture enables independent disinfection of the electronics and standard washing of the textile elements, ensuring thorough decontamination of all patient-contact surfaces.

FCC Certified Wireless Module

Integrated wireless communication maintains essential performance with FCC certification ensuring electromagnetic compatibility.

Our Implementation: FCC certified wireless module with robust RF shielding and filtering ensures reliable operation without electromagnetic interference.

Public Facing Document on PIPEDA Compliance

Introduction

The Personal Information Protection and Electronic Documents Act (PIPEDA) governs the collection and storage of digital medical data in Canada. At Fibra, we adhere to these requirements. This document contains information on why we collect data and how we protect the privacy of our users.

Accountability

The first requirement of PIPEDA compliance is designating a PIPEDA officer. Reach out to us with regards to compliance questions and our PIPEDA officer will respond as soon as possible. The name and relevant contact information of our PIPEDA officer is also available upon request.

Purposes of Data Collection

Fibra collects a wide range of patient data to provide the period tracking and ovulation prediction service. All data collected is collected to provide a specific service feature to users, and efforts are made to minimize data collection when possible. The list of data collected is given below, along with the specific purpose of collecting that data.

E-mail: e-mail is collected to authenticate the user’s identity and ensure that the user is able to access their data from any mobile device.
Discharge volume, heart rate, heart rate variability, discharge pH, and skin temperature: the biomarker data collected by the underwear sensors is used as input to the AI model responsible for predicting the menstrual cycle window based on biomarker data from a given day. These data points are necessary to provide an accurate estimate of the user’s current menstrual phase.
Period history, dates of past menstrual cycles, ovulation test results, history of AI model predictions: historical data on menstrual cycle windows either predicted by the AI model or provided by the user are used to predict the expected time and length of future menstrual cycle phases. They are also used to improve AI model performance.
History of menstrual flow, mood, cravings, insomnia, bloating, diarrhea, constipation, fatigue, discharge consistency, pregnancy test results, oral contraceptives: user provided data on symptoms history is recorded in order for users to have a record of past symptoms which they may use to estimate future symptom patterns or show to a health-care provider.
Fertility affecting disorders: by comparing the known fertility issues facing a user, we can improve model performance on future users with the same issue.

If purposes of data collection are ever changed, users will be immediately notified and consent to collect data will be recollected the next time they open the app.

Consent

An important element of PIPEDA is user consent. Users agree to data collection before they can access services provided by Fibra. The first time a user logs in to their account they are presented with our data collection policy, which they may either agree to or disagree to. Consent must be provided for all data categories at once, as data can’t be collected partially without compromising service quality.

Retention of Data

Data collected by Fibra is destroyed in the event that a user requests deletion of their account. No records of user biomarker, menstrual cycle, or symptom history is retained after account deletion. Data collected from currently active users is not deleted, as it is used to provide accurate AI predictions of future menstrual cycle phases as well as accurate predictions of the present cycle phase.

Accuracy

Biomarker data collected by Fibra is as accurate as possible, but may be affected by outside factors. Data regarding period and symptoms history is provided by the user, and is presumed accurate. If the user believes past data collection has been inaccurate, they may reach out to our PIPEDA accountability officer and request the data be updated for accuracy. The Biomarker data is collected frequently from the sensors in the underwear, and the data shown to the user is always the most up-to-date data available, with the time and date of collection clearly indicated in the app.

Security Safeguards

Data collected by Fibra is stored using a 3rd party tool provided by Google called “Firebase Cloud Firestore.” All data stored and retrieved from the Firestore tool is end-to-end encrypted, meaning it is protected from common cyber-attacks. Firestore complies with all major cybersecurity standards, including ISO 27001, ISO 27017, and ISO 27018. More details on the specific security measures provided to Fibra by Google’s database software are available in the firebase documentation. Data stored by Fibra is only accessible by the user the data was collected from. At no point is data retrieved containing private information from any other user. The database itself is accessible only by members of Fibra’s data science and hardware engineering teams, who have been trained on Fibra’s data collection policy.

Fibra does not sell nor provide access to user data to third parties.

Openness

The internal policy document regarding privacy and data collection is available upon request. You do not need to be a present or past customer of Fibra to request a copy of our policies and practices document. Reach out to the Fibra team and our PIPEDA officer will send you any requested documentation as soon as possible.

Users, past or present, are entitled to a full copy of the data collected from them upon request. Reach out to the Fibra team and our PIPEDA officer will send you csv files containing all currently retained data linked to your account. If you have previously deleted your account, it is possible that no data is currently stored, in which case you will be informed of this if you choose to request a copy of your data. All information requests are completely free.

Challenging Compliance

If you believe that Fibra is in violation of PIPEDA, reach out to the Fibra team immediately. An internal investigation will be conducted and you will be notified the results of this investigation and what steps were taken to bring Fibra back into compliance.

Medical Device Safety Compliance